Health Technology & Medical Devices — M2
HARDWA.HEALTHTE93CA.M2
Leads engineering teams developing medical devices and health technology from concept through regulatory approval, market launch, and post-market lifecycle management. Distinct from general hardware/electronics focuses through its grounding in medical device design controls (ISO 13485, FDA 21 CFR 820.30), risk management (ISO 14971), software lifecycle (IEC 62304), and electrical/usability standards (IEC 60601-1, IEC 62366). Managers in this focus own regulatory strategy, verification/validation, biocompatibility/sterilization/packaging constraints, and structured collaboration with clinical, regulatory, and manufacturing teams — alongside team leadership, mentorship, project plans, and budgets — using engineering and analysis tools such as SolidWorks, AutoCAD, Pro/Engineer, Mathcad, MATLAB, LabVIEW, Zuken, Minitab, SAS, three-dimensional motion capture software, and Microsoft Project.
Leads engineering teams developing medical devices and health technology from concept through regulatory approval, market launch, and post-market lifecycle management. Distinct from general hardware/electronics focuses through its grounding in medical device design controls (ISO 13485, FDA 21 CFR 820.30), risk management (ISO 14971), software lifecycle (IEC 62304), and electrical/usability standards (IEC 60601-1, IEC 62366). Managers in this focus own regulatory strategy, verification/validation, biocompatibility/sterilization/packaging constraints, and structured collaboration with clinical, regulatory, and manufacturing teams — alongside team leadership, mentorship, project plans, and budgets — using engineering and analysis tools such as SolidWorks, AutoCAD, Pro/Engineer, Mathcad, MATLAB, LabVIEW, Zuken, Minitab, SAS, three-dimensional motion capture software, and Microsoft Project.
Focus — Health Technology & Medical Devices
Leads engineering teams developing medical devices and health technology from concept through regulatory approval, market launch, and post-market lifecycle management. Distinct from general hardware/electronics focuses through its grounding in medical device design controls (ISO 13485, FDA 21 CFR 820.30), risk management (ISO 14971), software lifecycle (IEC 62304), and electrical/usability standards (IEC 60601-1, IEC 62366). Managers in this focus own regulatory strategy, verification/validation, biocompatibility/sterilization/packaging constraints, and structured collaboration with clinical, regulatory, and manufacturing teams — alongside team leadership, mentorship, project plans, and budgets — using engineering and analysis tools such as SolidWorks, AutoCAD, Pro/Engineer, Mathcad, MATLAB, LabVIEW, Zuken, Minitab, SAS, three-dimensional motion capture software, and Microsoft Project.
Material PAY and SKILL differential vs the function baseline.
Responsibilities by level
What this person actually does at each level on the management track — escalating scope, not one generic blob. Your level is highlighted.
- Supervises a unit of device engineers and technicians executing prototype builds, test execution, and design verification report writing, ensuring daily lab and bench work follows established design control practices
- Assigns and reviews task-scoped engineering work such as CAD drawings (AutoCAD, SolidWorks) and engineering calculations (Mathcad), test documentation, and data collection/organization, providing hands-on technical guidance within a single subsystem
- Ensures verification test runs and test method validations are executed on schedule and that requirements-to-risk-control traceability records are maintained per ISO 13485, applying statistical analysis (Minitab, SAS) to test data where required
- Monitors short-term unit goals and consumable/test budgets, escalating resource constraints and schedule risks to the engineering manager
- Provides functional expertise on mechanical design (molded plastic, sheet metal, cabling, PCBs) or electrical/firmware bench work, coaching individual contributors on standards such as IEC 60601-1 documentation
- 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
- Manages cross-functional coordination with suppliers and manufacturing on material/component selection and biocompatibility, sterilization, and packaging constraints for assigned device subsystems
- 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
- Makes tactical judgments within known design control and risk management factors, balancing schedule, verification coverage, and resource allocation across the team
- 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
- Manages a device engineering department or program team, owning operations and budgets for end-to-end design from concept through verification and regulatory submission support
- Evaluates diverse engineering issues and trends across multiple subsystems, defining mitigation approaches for design, V&V, and software lifecycle (IEC 62304) risks including SOUP documentation and assessment
- Leads functional or customer-facing teams and structures recurring collaboration with clinical, regulatory, and manufacturing partners to align device development with submission timelines
- Develops and executes project plans, timelines, and budgets (Microsoft Project), making decisions on staffing, supplier strategy, and design trade-offs to meet program commitments, and mentors senior and junior engineers on design controls and risk practices
- Owns regulatory strategy execution at the program level, ensuring compliance with FDA 21 CFR 820.30 and ISO 13485 across the department's deliverables
- Manages multiple device engineering departments or critical functions (e.g., systems, V&V, regulatory engineering), aligning team strategy with business objectives where failures could jeopardize device clearance or launch
- Sets strategic policies for design controls, risk management, and verification/test method validation across programs, defining standards that govern multiple device platforms
- Engages senior leaders on functional engineering strategy, regulatory posture, and platform roadmaps, and brokers cross-functional alignment among clinical, regulatory, and manufacturing organizations
- Oversees risk assessment and post-market lifecycle management across a portfolio, ensuring traceability and compliance under ISO 14971, IEC 62304, and IEC 60601-1/62366
- Makes complex multi-program decisions on platform architecture, supplier qualification, and technology investments that affect multiple device programs and client-specific lifecycle deliverables, while building bench strength through mentorship of managers and senior engineers
- Directs the medical device engineering organization through subordinate managers, impacting division-wide operations including device portfolio strategy, regulatory readiness, and launch outcomes
- Defines methods and organization-wide standards for design controls, risk management, verification/validation, and software lifecycle compliance across all device platforms
- Influences executives and major customers on key device strategy, quality system posture, and platform investment decisions, shaping how the organization positions its devices for clinical adoption
- Owns engineering budgets, headcount planning, and organizational capability across device development and post-market lifecycle, directing strategic areas with business-wide implications
- Sets long-term technical and regulatory direction for the organization, resolving the most ambiguous, high-impact problems spanning multiple programs and the post-market environment
Level guidelines
The universal leveling rubric applied to this function — how scope, complexity, collaboration, and experience step up across levels.
| Level | Knowledge & Application | Complexity & Problem Solving | Collaboration & Interaction | Typical Degree & Years |
|---|---|---|---|---|
| M1 | Functional expert in a device engineering discipline (mechanical, electrical, firmware, or test) applying established design control and verification practices to supervise unit-level execution. | Limited scope; resolves day-to-day execution issues within established procedures and a single subsystem, escalating ambiguous design or compliance questions. | Daily interactions with unit staff and engineering peers; coordinates with lab and test resources to keep verification work on track. | Functional expert with some leadership exposure, typically gained through senior IC or lead engineer roles. |
| M2 | Applies broad device development knowledge across subsystems, owning module-level design and verification while making tactical judgments within known design control and risk factors. | Solves problems by exercising judgment within known factors, balancing verification coverage, supplier constraints, and schedule across a skilled team. | Cross-functional cooperation with suppliers, manufacturing, clinicians/users, and adjacent engineering teams on subsystem integration and requirements. | 2–5 years in team leadership or specialist device engineering roles. |
| M3 | Applies department-level expertise in end-to-end device development and regulatory strategy, evaluating trends and diverse issues across multiple subsystems and mentoring professionals. | Addresses diverse engineering and compliance issues requiring trend evaluation across design, V&V, and software lifecycle domains. | Leads functional or customer teams; structures recurring collaboration with clinical, regulatory, and manufacturing partners on program direction. | 5–7+ years managing professionals and budgets in medical device development. |
| M4 | Applies strategic policy knowledge across multiple departments, aligning engineering standards for design controls and risk with business objectives where failures could jeopardize clearance or launch. | Resolves strategic, cross-program issues, defining policies and standards that govern multiple device platforms and lifecycle deliverables. | Engages senior leaders on functional strategy and brokers alignment across clinical, regulatory, and manufacturing organizations. | 8–10+ years with complex team/org leadership in medical device engineering. |
| M5 | Defines organization-wide methods and standards for device development and regulatory compliance, applying complex org-wide judgment across the full portfolio. | Resolves the most complex, ambiguous, org-wide problems spanning multiple programs and the post-market lifecycle, defining methods others follow. | Influences executives and major customers on key device strategy and quality posture; leads through subordinate department managers. | 10–12+ years including second-level management and division-level strategy work. |
Skills
Focus-specific skills the role applies — the relevance layer beyond the occupational base.
- Design controls
- Knowledge of medical device design control requirements per ISO 13485 and FDA 21 CFR 820.30.
- Risk management (ISO 14971)
- Classifying device safety based on potential harm, identifying hazards from failures or misuse, implementing controls to reduce risks, and maintaining traceability from hazard identification to mitigation validation.
- Software lifecycle (IEC 62304)
- Managing medical device software development lifecycle, including handling Software of Unknown Provenance (SOUP) by documenting and assessing third-party software.
- Verification and validation
- Designing and executing design verification and test method validations, ensuring requirements are verified and validated under ISO 13485.
- Requirements-to-risk traceability
- Mapping each requirement back to risk controls defined in ISO 14971 and verifying/validating under ISO 13485.
- Electrical/usability standards
- Advanced knowledge of FDA, IEC and UL standards for medical electronic equipment, including IEC 60601-1 and IEC 62366.
- Clinical requirements analysis
- Understanding clinical requirements by discussing with clinicians or users, reviewing literature, and analyzing existing products and IP.
- Mechanical design
- Design of molded plastic or cast parts, sheet metal, cabling, and PCBs.
- Cross-disciplinary integration
- Integrating electromechanical, firmware, and software components in collaborative device development.
- Mentorship and technical leadership
- Mentoring and developing junior engineers and providing technical direction.
- Statistical analysis tools
- Uses Minitab and SAS effectively to analyze test and verification data during day-to-day device development tasks.
- CAD and engineering analysis tools
- Uses AutoCAD, SolidWorks, Pro/Engineer, and Mathcad effectively for mechanical design and engineering calculations.
- Project management tools
- Uses Microsoft Project effectively to develop and execute device program plans, timelines, and budgets.
Provenance
The evidence base behind this profile — every layer is sourced; quality is scored by an adversarial review panel (1–5; passes at ≥4 on the minimum dimension).
Level — M2 — Manager II
Manages an established team or sub-function; owns planning and performance for the group.
- Scope
- An established team or sub-function
- Autonomy
- Owns planning for the group
- Complexity
- Cross-project coordination and priorities
- Impact
- Group delivery and development
- Decision rights
- Owns staffing, priorities, performance for the group
- Leadership
- Manages a team; sometimes manages leads
- Typical experience
- 5–8 yrs
Adjacent roles
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