← Health Technology & Medical Devices — M2

Goal templates — Health Technology & Medical Devices — M2

Hardware & Health Technology Engineering · Health Technology & Medical Devices · M2 — Manager II

These are canon-derived frames, not advice: every line is either verbatim JobFrame canon text or a fixed template wrapping it. ⟨target⟩ / ⟨baseline⟩ / ⟨date⟩ are placeholders for the manager to fill in. Nothing here is generated by AI — rows are omitted, never invented, when the canon lacks the underlying field.

SMART goals

One row per canon core output / responsibility this level owns.

JFM responsibility (M2)

Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes

Specific: Deliver: "Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
Relevant: Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
Time-bound: ⟨date⟩

JFM responsibility (M2)

Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems

Specific: Deliver: "Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
Relevant: Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
Time-bound: ⟨date⟩

JFM responsibility (M2)

Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness

Specific: Deliver: "Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
Relevant: Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
Time-bound: ⟨date⟩

JFM responsibility (M2)

Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team

Specific: Deliver: "Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
Relevant: Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
Time-bound: ⟨date⟩

JFM responsibility (M2)

Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates

Specific: Deliver: "Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
Relevant: Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
Time-bound: ⟨date⟩

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1. Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
   Relevant:    Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

2. Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
   Relevant:    Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

3. Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
   Relevant:    Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

4. Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
   Relevant:    Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

5. Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team."
   Relevant:    Advances the Hardware & Health Technology Engineering · Health Technology & Medical Devices mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

OKRs

Objectives from this level's core outputs; key results only where a real dimension or capability backs them.

JFM responsibility (M2)

Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes"
Evidence at this level's scope bar: "An established team or sub-function" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems"
Evidence at this level's autonomy bar: "Owns planning for the group" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness"
Evidence at this level's complexity bar: "Cross-project coordination and priorities" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team"
Evidence at this level's impact bar: "Group delivery and development" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates"
Evidence at this level's decision rights bar: "Owns staffing, priorities, performance for the group" — ⟨target⟩ by ⟨date⟩

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Objective 1: Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes"
  KR2. Evidence at this level's scope bar: "An established team or sub-function" — ⟨target⟩ by ⟨date⟩

Objective 2: Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems"
  KR2. Evidence at this level's autonomy bar: "Owns planning for the group" — ⟨target⟩ by ⟨date⟩

Objective 3: Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness"
  KR2. Evidence at this level's complexity bar: "Cross-project coordination and priorities" — ⟨target⟩ by ⟨date⟩

Objective 4: Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team"
  KR2. Evidence at this level's impact bar: "Group delivery and development" — ⟨target⟩ by ⟨date⟩

Objective 5: Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates"
  KR2. Evidence at this level's decision rights bar: "Owns staffing, priorities, performance for the group" — ⟨target⟩ by ⟨date⟩

MBO areas

Key result areas from this level's responsibilities, each with a standard grounded in the canon leveling rubric where one exists.

Area	Standard	Target	Due
Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes	Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."	⟨target⟩	⟨date⟩
Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems	Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."	⟨target⟩	⟨date⟩
Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness	Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."	⟨target⟩	⟨date⟩
Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team	Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."	⟨target⟩	⟨date⟩
Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates	Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."	⟨target⟩	⟨date⟩

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1. Area: Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."
   Target:   ⟨target⟩   Due: ⟨date⟩

2. Area: Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."
   Target:   ⟨target⟩   Due: ⟨date⟩

3. Area: Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."
   Target:   ⟨target⟩   Due: ⟨date⟩

4. Area: Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."
   Target:   ⟨target⟩   Due: ⟨date⟩

5. Area: Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors."
   Target:   ⟨target⟩   Due: ⟨date⟩

Scorecard

Only perspectives with real canon backing are shown — no Financial or Customer perspective, since nothing in the canon grounds business-financial or customer measures for a role alone.

Internal process

"Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes"→ ⟨target⟩ by ⟨date⟩
"Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems"→ ⟨target⟩ by ⟨date⟩
"Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness"→ ⟨target⟩ by ⟨date⟩
"Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team"→ ⟨target⟩ by ⟨date⟩
"Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates"→ ⟨target⟩ by ⟨date⟩

Role calibration

Meets the scope bar: "An established team or sub-function"→ ⟨target⟩ by ⟨date⟩
Meets the autonomy bar: "Owns planning for the group"→ ⟨target⟩ by ⟨date⟩
Meets the complexity bar: "Cross-project coordination and priorities"→ ⟨target⟩ by ⟨date⟩
Meets the impact bar: "Group delivery and development"→ ⟨target⟩ by ⟨date⟩
Meets the decision rights bar: "Owns staffing, priorities, performance for the group"→ ⟨target⟩ by ⟨date⟩
Meets the leadership bar: "Manages a team; sometimes manages leads"→ ⟨target⟩ by ⟨date⟩

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Internal process
  - "Leads a skilled team of design engineers owning design modules and subsystems with reduced oversight, holding the team accountable for verification plan completion and tactical milestone outcomes"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Translates clinical and user requirements into engineering specifications across the team's modules — coordinating with clinicians and reviewing literature, existing products, and IP — and checks requirements-to-risk traceability for completeness"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Owns the team's contribution to design history files and risk management files (ISO 14971), reviewing hazard analyses and mitigation evidence (using Minitab and three-dimensional motion capture data where applicable) before stage gates"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]

Role calibration
  - Meets the scope bar: "An established team or sub-function"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Scope)]
  - Meets the autonomy bar: "Owns planning for the group"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Autonomy)]
  - Meets the complexity bar: "Cross-project coordination and priorities"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Complexity)]
  - Meets the impact bar: "Group delivery and development"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Impact)]
  - Meets the decision rights bar: "Owns staffing, priorities, performance for the group"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Decision rights)]
  - Meets the leadership bar: "Manages a team; sometimes manages leads"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Leadership)]