← Medical Device Product Development — P7

Goal templates — Medical Device Product Development — P7

R&D Science & Engineering · Medical Device Product Development · P7 — Staff / Distinguished Professional

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 (P7)

Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes

Specific: Deliver: "Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
Relevant: Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
Time-bound: ⟨date⟩

JFM responsibility (P7)

Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences

Specific: Deliver: "Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
Relevant: Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
Time-bound: ⟨date⟩

JFM responsibility (P7)

Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices

Specific: Deliver: "Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
Relevant: Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
Time-bound: ⟨date⟩

JFM responsibility (P7)

Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice

Specific: Deliver: "Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
Relevant: Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
Time-bound: ⟨date⟩

JFM responsibility (P7)

Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports

Specific: Deliver: "Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
Relevant: Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
Time-bound: ⟨date⟩

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1. Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes  [source: JFM responsibility (P7)]
   Specific:    Deliver: "Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
   Relevant:    Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
   Time-bound:  ⟨date⟩

2. Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences  [source: JFM responsibility (P7)]
   Specific:    Deliver: "Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
   Relevant:    Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
   Time-bound:  ⟨date⟩

3. Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices  [source: JFM responsibility (P7)]
   Specific:    Deliver: "Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
   Relevant:    Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
   Time-bound:  ⟨date⟩

4. Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice  [source: JFM responsibility (P7)]
   Specific:    Deliver: "Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
   Relevant:    Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
   Time-bound:  ⟨date⟩

5. Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports  [source: JFM responsibility (P7)]
   Specific:    Deliver: "Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps."
   Relevant:    Advances the R&D Science & Engineering · Medical Device Product Development mandate for a P7 — Staff / Distinguished Professional.
   Time-bound:  ⟨date⟩

OKRs

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

JFM responsibility (P7)

Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes"
Evidence at this level's scope bar: "Cross-organization / enterprise technical strategy" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P7)

Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences"
Evidence at this level's autonomy bar: "Operates autonomously at the enterprise level" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P7)

Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices"
Evidence at this level's complexity bar: "Industry-level, highly ambiguous problems" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P7)

Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice"
Evidence at this level's impact bar: "Enterprise-wide" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P7)

Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports"
Evidence at this level's decision rights bar: "Final technical authority across multiple domains" — ⟨target⟩ by ⟨date⟩

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Objective 1: Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes  [source: JFM responsibility (P7)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes"
  KR2. Evidence at this level's scope bar: "Cross-organization / enterprise technical strategy" — ⟨target⟩ by ⟨date⟩

Objective 2: Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences  [source: JFM responsibility (P7)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences"
  KR2. Evidence at this level's autonomy bar: "Operates autonomously at the enterprise level" — ⟨target⟩ by ⟨date⟩

Objective 3: Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices  [source: JFM responsibility (P7)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices"
  KR2. Evidence at this level's complexity bar: "Industry-level, highly ambiguous problems" — ⟨target⟩ by ⟨date⟩

Objective 4: Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice  [source: JFM responsibility (P7)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice"
  KR2. Evidence at this level's impact bar: "Enterprise-wide" — ⟨target⟩ by ⟨date⟩

Objective 5: Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports  [source: JFM responsibility (P7)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports"
  KR2. Evidence at this level's decision rights bar: "Final technical authority across multiple domains" — ⟨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
Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes	Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."	⟨target⟩	⟨date⟩
Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences	Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."	⟨target⟩	⟨date⟩
Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices	Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."	⟨target⟩	⟨date⟩
Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice	Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."	⟨target⟩	⟨date⟩
Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports	Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."	⟨target⟩	⟨date⟩

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1. Area: Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes  [source: JFM responsibility (P7) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."
   Target:   ⟨target⟩   Due: ⟨date⟩

2. Area: Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences  [source: JFM responsibility (P7) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."
   Target:   ⟨target⟩   Due: ⟨date⟩

3. Area: Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices  [source: JFM responsibility (P7) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."
   Target:   ⟨target⟩   Due: ⟨date⟩

4. Area: Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice  [source: JFM responsibility (P7) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."
   Target:   ⟨target⟩   Due: ⟨date⟩

5. Area: Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports  [source: JFM responsibility (P7) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice."
   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

"Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes"→ ⟨target⟩ by ⟨date⟩
"Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences"→ ⟨target⟩ by ⟨date⟩
"Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices"→ ⟨target⟩ by ⟨date⟩
"Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice"→ ⟨target⟩ by ⟨date⟩
"Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports"→ ⟨target⟩ by ⟨date⟩

Role calibration

Meets the scope bar: "Cross-organization / enterprise technical strategy"→ ⟨target⟩ by ⟨date⟩
Meets the autonomy bar: "Operates autonomously at the enterprise level"→ ⟨target⟩ by ⟨date⟩
Meets the complexity bar: "Industry-level, highly ambiguous problems"→ ⟨target⟩ by ⟨date⟩
Meets the impact bar: "Enterprise-wide"→ ⟨target⟩ by ⟨date⟩
Meets the decision rights bar: "Final technical authority across multiple domains"→ ⟨target⟩ by ⟨date⟩
Meets the leadership bar: "Sets technical direction org-wide; develops principals"→ ⟨target⟩ by ⟨date⟩

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Internal process
  - "Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P7)]
  - "Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P7)]
  - "Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P7)]
  - "Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P7)]
  - "Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P7)]

Role calibration
  - Meets the scope bar: "Cross-organization / enterprise technical strategy"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Scope)]
  - Meets the autonomy bar: "Operates autonomously at the enterprise level"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Autonomy)]
  - Meets the complexity bar: "Industry-level, highly ambiguous problems"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Complexity)]
  - Meets the impact bar: "Enterprise-wide"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Impact)]
  - Meets the decision rights bar: "Final technical authority across multiple domains"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Decision rights)]
  - Meets the leadership bar: "Sets technical direction org-wide; develops principals"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Leadership)]