Engineering Rnd interview prep.

Mechanical, electrical, biomedical, software engineers + algorithm + firmware folks working on Class I/II/III devices - from cardiac stents to surgical robotics to infusion pumps to digital health software-as-a-medical-device (SaMD).

What interviewers look for

  • Can the candidate execute engineering work within design controls + ISO 13485 discipline without slowing down?
  • Do they understand the regulatory pathway implications of design choices - 510(k) predicate alignment, De Novo, PMA?
  • Are they fluent in risk management (ISO 14971) + V&V discipline + design history file?
  • Can they think clinical use case - what does the surgeon / patient / nurse actually need + the failure modes?
  • Do they collaborate cross-functionally with Quality, Regulatory, Clinical, Marketing without friction?
  • Are they fluent in safety standards - IEC 60601 for electrical, IEC 62304 for software, biocompatibility for contact?
  • Long-game fit - tech lead / principal / chief engineer trajectory, or moving into product / regulatory?

Behavioural questions to expect

  1. Walk me through your engineering background + device experience.

    What it tests: Story arc - engineering training, device exposure, regulatory awareness.

  2. Tell me about a device project you've led or significantly contributed to.

    What it tests: Engineering rigor + regulatory + clinical discipline.

  3. Why medical devices over other engineering paths (consumer / auto / aerospace / pure software)?

    What it tests: Authentic alignment - patient impact, regulatory discipline draw, complex multi-disciplinary work.

  4. Why this device space?

    What it tests: Specificity. Generic answers fail.

  5. Why this firm?

    What it tests: Real homework - product, recent events, engineering culture - not name-drop.

  6. What's your read on our product portfolio + R&D pipeline?

    What it tests: Industry literacy - product position, recent launches, competitive picture.

  7. Tell me what you understand about our quality + regulatory posture.

    What it tests: QSR + ISO 13485 + regulatory fluency - and this firm's specific record.

  8. Walk me through a project you executed under design controls.

    What it tests: Design control discipline - DHF, design inputs / outputs, V&V, traceability.

Technical concepts to master

Design controls + Design History File (DHF)

Design inputs
Documented requirements derived from intended use, user needs, regulatory + clinical requirements.
Design outputs
Drawings, specifications, code - the form of the device. Each traceable to a design input.
Design review
Formal review at design phase milestones - cross-functional, documented, with independent reviewer.
Verification vs Validation
Verification = design output meets design input. Validation = device meets user need + intended use.

ISO 14971 risk management

Risk management process
Risk analysis -> evaluation -> control -> residual risk evaluation -> overall risk acceptability -> production + post-production information.
Hazard + harm + risk
Hazard = potential source of harm. Risk = probability + severity of harm. Harm = injury or damage.
Risk control hierarchy
Inherent safety by design -> protective measures -> information for safety (labelling, training).
FMEA + fault tree analysis
FMEA = bottom-up failure mode + effects analysis. FTA = top-down deductive analysis of system failure.

V&V + clinical evaluation

Design verification
Testing that design output meets design input - bench, simulation, environmental, EMC.
Design validation
Testing that device meets user need + intended use - typically with users + actual or simulated clinical use.
Clinical evaluation (EU MDR)
Systematic assessment of clinical data demonstrating safety + performance per EU MDR Article 61.
Post-market clinical follow-up (PMCF)
Ongoing collection of clinical data after device launch to confirm safety + performance.

IEC 62304 + Software as a Medical Device

Software safety classification
IEC 62304 Class A (no harm possible), B (non-serious injury possible), C (death / serious injury possible) - drives life-cycle rigor.
Software life cycle (62304)
Planning, requirements, architecture, design, implementation, integration testing, system testing, release; configuration management + maintenance across.
SaMD (Software as a Medical Device)
Software intended for medical purpose without being part of hardware medical device - per IMDRF.
AI / ML in medical devices
AI/ML-based SaMD increasingly regulated; FDA published predetermined change control plan guidance.

Practical drills

  • You're R&D lead for a new Class II surgical instrument. Walk through your design control + V&V approach from concept to design transfer.
  • Late in V&V, you discover a use error in your device that wasn't captured in earlier usability work - potential for serious harm. Walk through your risk management + design response.
  • Your team is developing a novel device with no clear predicate. Walk through pathway options + engineering implications.

Smart-question anchors

  • Product portfolio + pipeline - recent launches + upcoming submissions
  • Engineering org structure - functional vs program, R&D vs Quality + Regulatory ratio
  • Quality system maturity - QSR + ISO 13485 + EU MDR + Notified Body relationships
  • Innovation tempo + breakthrough device participation - culture signals
  • Cross-functional dynamics - R&D / Clinical / Regulatory / Marketing collaboration

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