Senior Product Development Engineer

• Led design & development/sustenance of

  Class II/III medical devices

  (electromechanical, disposable, implantable).
• Managed

  Design History Files (DHF)

  and ensured compliance with

  ISO 13485

  ,

  IEC 60601

  ,

  FDA

  &

  EU MDR

  .
• Led

  risk management (ISO 14971)

  activities including

  FMEA (Design & Process)

  and hazard analysis.
• Developed

  design inputs/outputs, V&V plans

  , test protocols, and technical reports.
• Collaborated with cross-functional teams (QA, RA, Manufacturing, Supply Chain, Clinical) for

  design transfer

  .
• Conducted

  design reviews

  to ensure safety, reliability, and manufacturability.
• Executed

  test method & process validations

  ; supported

  FEA

  coordination for design analysis.
• Contributed to

  regulatory submissions

  (510(k), CE Mark, MDR) with technical documentation.
• Led

  engineering change management

  using electronic change control systems.
• Supported

  process improvement

  initiatives in product development lifecycle.

Preferred candidate profile

• Proven experience in

  design, development, and design sustenance

  of medical devices.
• Strong knowledge of

  FDA 21 CFR Part 820

  ,

  EU MDR

  , and

  ISO standards

  (ISO 13485, ISO 14971).
• Hands-on expertise in

  risk management

  using tools like

  DFMEA

  , aligned with

  ISO 14971

  .
• Skilled in preparing and remediating

  Design History Files (DHF)

  and authoring

  technical documents

  such as test protocols/reports and risk management reports.
• Experienced in identifying and executing

  verification and validation (V&V)

  requirements.
• Knowledge of

  test method validation

  ,

  process validation

  , and

  design change management

  .
• Proficient in

  tolerancing (GD&T)

  and

  tolerance stack-up analysis

  (statistical and worst-case).
• Familiar with

  Design for Six Sigma (DFSS)

  ,

  statistical methods

  , and

  Design of Experiments (DoE)

  .
• Strong grasp of

  design controls

  ,

  biocompatibility (ISO 10993)

  ,

  usability (IEC 62366)

  , and

  electrical safety (IEC 60601)

  .
• Understanding of

  Software as a Medical Device (SaMD)

  considerations.