Engineering Rnd

Engineering Rnd interview prep.

The library content Coach uses to tailor reports for this role. Generated reports personalise this against the candidate's CV + the firm's context.

Behavioural questions to expect

  1. Walk me through your engineering background + device experience.
  2. Tell me about a device project you've led or significantly contributed to.
  3. Why medical devices over other engineering paths (consumer / auto / aerospace / pure software)?
  4. Why this device space?
  5. Why the firm?
  6. What's your read on our product portfolio + R&D pipeline?
  7. Tell me what you understand about our quality + regulatory posture.
  8. Walk me through a project you executed under design controls.

Technical concepts to master

  • Design controls + Design History File (DHF)

    Design inputs · Design outputs · Design review · Verification vs Validation · Design History File (DHF)

  • ISO 14971 risk management

    Risk management process · Hazard + harm + risk · Risk control hierarchy · FMEA + fault tree analysis · Residual risk + benefit-risk

  • V&V + clinical evaluation

    Design verification · Design validation · Clinical evaluation (EU MDR) · Post-market clinical follow-up (PMCF) · Usability engineering (IEC 62366)

  • IEC 62304 + Software as a Medical Device

    Software safety classification · Software life cycle (62304) · SaMD (Software as a Medical Device) · AI / ML in medical devices · Cybersecurity

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

Sourced from

FDA 21 CFR Part 820 (Quality System Regulation) + FDA medical device guidances · ISO 13485:2016 + ISO 14971:2019 + IEC 60601 / 62304 / 62366 standards · EU MDR (Regulation 2017/745) + Notified Body guidances · IMDRF SaMD framework + FDA SaMD + AI / ML guidance · AAMI standards + AdvaMed industry guidances

Try Coach with your CV

Drop your CV and a job description. Coach returns a tailored prep report + cheat sheet in 5 minutes. First report is free.

Generate my first prep