P1
RDSCIE.MEDICALD0AE6.P1
Medical Device Product Development — P1
R&D Science & Engineering
Medical Device Product Development — P1
RDSCIE.MEDICALD0AE6.P1
P1P1 — Entry-Level Professionalverified1.00approvedglobalv1
Medical Device Product Development — the design, development, verification/validation, risk management, and design transfer of novel medical devices and combination products under design controls (FDA 21 CFR 820, ISO 14971). Distinct from general mechanical or software engineering focuses in its regulated environment: every design decision is traced through the Design History File, validated against user needs, and transferred to manufacturing under documented design control. Covers CAD/FEA design, materials/biocompatibility, test method development, and regulatory strategy for active and passive devices.
Level
P1 · P1 — Entry-Level Professional · 0–2 yrs
Function · Focus
R&D Science & Engineering · Medical Device Product Development
Market pay (median)
$62k ($49k–$79k)
Pay basis
Medical Device Product Development — the design, development, verification/validation, risk management, and design transfer of novel medical devices and combination products under design controls (FDA 21 CFR 820, ISO 14971). Distinct from general mechanical or software engineering focuses in its regulated environment: every design decision is traced through the Design History File, validated against user needs, and transferred to manufacturing under documented design control. Covers CAD/FEA design, materials/biocompatibility, test method development, and regulatory strategy for active and passive devices.
Focus — Medical Device Product Development
Medical Device Product Development — the design, development, verification/validation, risk management, and design transfer of novel medical devices and combination products under design controls (FDA 21 CFR 820, ISO 14971). Distinct from general mechanical or software engineering focuses in its regulated environment: every design decision is traced through the Design History File, validated against user needs, and transferred to manufacturing under documented design control. Covers CAD/FEA design, materials/biocompatibility, test method development, and regulatory strategy for active and passive devices.
Material SKILL differential vs the function baseline.
Responsibilities by level
What this person actually does at each level on the professional track — escalating scope, not one generic blob. Your level is highlighted.
P1this profile
- Works under the supervision of a senior engineer on a defined slice of a device project, typically a sustaining or incremental task, following detailed instruction
- Collects and analyzes test data, generates summary reports, and documents results into the Design History File per established templates
- Builds and maintains development medical devices, automated test equipment, and test fixtures used to characterize device performance
- Performs basic CAD modeling of components in SolidWorks or AutoCAD under direction and routine measurement using calibrated hand tools and instruments
- Executes predefined verification test protocols and records observations against acceptance criteria
P2
- Independently performs detailed phases of engineering work on conventional device tasks, ensuring assigned tasks are completed on time and within budget under general instruction
- Develops CAD models, performs tolerance stack analysis and material selection, and supports DFMEA/PFMEA activities for assigned components
- Drafts verification and validation protocols and executes them, confirming the device was built per design plans
- Coordinates with quality assurance, regulatory affairs, and manufacturing on assigned product tasks
- Supports design transfer activities such as documentation of design outputs and pilot/clinical build records
P3
- Leads projects of moderate scope and duration, defining project scope, schedule, team roles, and responsibilities with milestone-level review
- Independently coordinates detailed phases of engineering work across the design control elements (input, output, review, verification, validation)
- Develops and implements new products jointly with Manufacturing, owning design transfer of an assigned product feature or subsystem
- Performs FEA/simulation and engineering analysis on diverse device problems, evaluating identifiable factors to select design approaches
- Mentors junior engineers or technicians and applies ISO 14971 risk management to assigned product area
P4
- Designs, develops, tests, and supports manufacture of novel medical device products, leading in-depth analysis of complex design variables
- Leads test method development and validation for an assigned product development area, selecting methods and approaches
- Leads risk management activity (DFMEA, ISO 14971 hazard analysis) for assigned product development area
- Compiles and manages technical reviews and leads the design transfer of products from development to commercial manufacture
- Coordinates across quality, regulatory, and manufacturing groups and may supervise or lead a project team
P5
- Formulates new, innovative approaches to solve technical problems on strategic or unique device development assignments contributing to company objectives
- Executes creation of new product development and lifecycle deliverables — plans, product requirements, and risk documentation — for complex devices and combination products
- Acts as technical lead on device development and testing programs with high independence, owning verification/validation strategy across systems
- Builds influential networks and serves as a technical spokesperson with regulatory bodies, suppliers, and clinical partners on device design matters
- Resolves intangible design and biocompatibility trade-offs (materials, software/firmware validation, metrology) where precedent is limited
P6
- Fulfills the technical lead role on multiple device development and testing projects with minimal supervision, architecting systems across the product portfolio
- Owns regulatory strategy and design control architecture for organization-wide device programs, shaping standards for the design control function
- Proactively identifies areas of project and technical risk, escalates expediently, and drives portfolio-level solutions
- Supervises engineers, technologists, technicians, and interns directly or indirectly and provides high-level technical mentorship
- Interfaces with executives on device development roadmaps and influences design and risk-management practice across the organization
P7
- Sets long-term technical direction for the medical device R&D function, anticipating emerging challenges in device technologies, materials, and regulatory landscapes
- Develops new device development methods, models, or platform architectures, solving precedent-free problems with broad business and industry consequences
- Operates with complete independence to define multi-program roadmaps and architectural governance for combination products and active devices
- Networks with executives, regulators (FDA), standards bodies, and industry leaders to shape and educate on device development and risk-management practice
- Provides high-level mentorship to senior and principal engineers and shapes company-wide device engineering capability without necessarily holding direct reports
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 |
|---|---|---|---|---|
| P1 | Applies foundational mechanical/biomedical engineering knowledge to routine tasks; uses CAD and basic metrology under detailed instruction within established procedures. | Solves routine problems with standard answers; data collection and documentation against defined templates and protocols. | Maintains stable internal relationships, reporting to and learning from a senior engineer managing the project. | 0–1 years; new graduate or intern in biomedical/mechanical engineering. |
| P2 | Applies design control and analysis fundamentals (tolerance stacks, material selection, DFMEA/PFMEA) to conventional device tasks in familiar contexts. | Moderate complexity; exercises judgment in familiar engineering contexts following defined procedures with some routine independence. | Builds productive project relationships with QA, regulatory, and manufacturing on assigned tasks. | 2+ years with BA, or MS/PhD with no experience (Engineer II). |
| P3 | Applies broad design control knowledge across input/output/verification/validation; evaluates identifiable factors to select approaches on diverse device problems. | Plans and coordinates detailed phases of work with day-to-day independence; resolves diverse problems with milestone review. | Networks with senior professionals; coordinates project activities and mentors junior staff across cross-functional teams. | 5+ years (BA), 3 years (MA), or PhD without experience (Engineer III). |
| P4 | Applies in-depth device engineering expertise to complex issues with functional impact; owns test method development/validation and risk management for a product area. | Performs in-depth analysis of complex, interdependent design variables; selects methods and resolves complex test/risk challenges. | Coordinates across quality, regulatory, and manufacturing groups; influences design decisions and may lead a project team. | 8+ years, often with graduate education (Senior R&D Engineer). |
| P5 | Recognized expert applying intangibles to strategic/unique device development; formulates innovative approaches across novel materials, software validation, and combination products. | Solves significant precedent-thin problems with high independence on broad or special assignments contributing to company objectives. | Builds influential internal and external networks; serves as technical spokesperson with regulators, suppliers, and clinical partners. | 12+ years with extensive device development expertise. |
| P6 | Provides field-shaping device architecture and design control expertise; technical lead on multiple programs owning regulatory strategy organization-wide. | Visionary problem-solving on critical, broad-design challenges with wide latitude; drives portfolio-level risk and architecture decisions. | Influences organization and industry practice; supervises engineers and mentors peers; interfaces with executives. | 15+ years; principal device expert, often PhD plus industry leadership. |
| P7 | Advances the field of medical device development; develops new methods, platform architectures, and theories that influence industry practice. | Solves ambiguous, precedent-free problems with broad business/industry consequences; defines long-term technical roadmaps. | Networks with executives, boards, regulators, and industry leaders; persuades and educates senior stakeholders on strategic priorities. | 20+ years, or equivalent recognition (often PhD plus patents, publications, or significant industry contributions). |
Skills
Focus-specific skills the role applies — the relevance layer beyond the occupational base.
- CAD and 3D Modeling
- Uses 3D CAD software such as SolidWorks, AutoCAD, or ProE for functional design and CAD modeling of medical devices.
- FEA and Simulation
- Performs finite element analysis and uses simulation tools to evaluate device mechanical and physical behavior during engineering analysis.
- Engineering Analysis
- Conducts tolerance stack analysis, material selection, and risk analysis to inform robust device design decisions.
- Design for Manufacturing / Quality Engineering
- Performs DFMEA and PFMEA, applies Geometric Dimensioning and Tolerancing, design control, design and process validations, Gauge R&R, test method validations, pilot manufacturing for clinical builds, and design transfer for commercial manufacturing.
- Materials Science and Biocompatibility
- Applies knowledge of organic and non-organic material properties (steel, ceramic, glass, mesh, porous, nanotech) and biocompatibility to device material selection.
- Design Controls
- Operationalizes the nine design control elements — planning, input, output, review, verification, validation, transfer, design changes, and the Design History File.
- Risk Management
- Applies ISO 14971 for medical device risk management to complement and satisfy design control requirements.
- Verification and Validation
- Confirms via verification that the device was designed correctly per plans and via validation that the device meets user needs.
- Medical Device Software Development
- Develops software and firmware for active devices including software validation and associated regulatory requirements.
- Metrology and Measurement
- Applies principles and practices of metrology using precision components, hand tools, calibrated instruments, and measurement equipment.
- Documentation
- Owns records such as the Design History File (DHF) and Device History Record (DHR).
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 differentiation5.0Focus specificity5.0Concreteness5.0Factual accuracy5.0Real-world coverage5.0
17 sources
- onetonline.org/link/summary/17-2031.00
- bls.gov/ooh/architecture-and-engineering/biomedical-engineers.htm
- engineeringonline.ucr.edu/blog/medical-device-engineering/
- quora.com R&D engineer thread
- galenrobotics.com PDE job description
- shobhituniversity.ac.in
- glassdoor.com
- ziprecruiter.com
- seliomedical.com Senior R&D Engineer spec
- surfsearch.org
- edgeonemedical.com/principal-device-engineer
- fladgerassociates.net
- careers.embs.org
- arterexmedical.com
- complizen.ai
- cognidox.com
- fda.gov media/73141
Level — P1 — Entry-Level Professional
New to role or field; performs basic tasks under supervision
- Scope
- Own tasks within a defined component
- Autonomy
- Close supervision; work reviewed frequently
- Complexity
- Routine problems with known solutions
- Impact
- Own deliverables
- Decision rights
- Few independent decisions; escalates the rest
- Leadership
- None — building the craft
- Typical experience
- 0–2 yrs
Adjacent roles
Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →
M1
RDSCIE.BIOTECHR5DD3.M1
Biotech R&D — M1
M2
RDSCIE.BIOTECHR5DD3.M2
Biotech R&D — M2
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O*NET / SOC
- code=17-2031source=jfm-factory.resolve