Senior Mechanical Engineer

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Senior Mechanical Engineer

At ONWARD we're looking for a Senior Mechanical Engineer to join our team.
Full-time · Lausanne

About the job

ONWARD Medical is hiring a Sr Mechanical Engineer as part of the product development team that designs, develops, and implements medical devices for electrical spinal cord stimulation. Within the multi-disciplinary team, you will be responsible for the mechanical engineering of implantable and/or external spinal cord stimulation devices, body worn devices, the design of mechanical tests, test fixtures and interface with manufacturing.

Responsibilities

  • Drive the design, development, manufacturing, and testing of new generations and continuous improvements of our  neurostimulators, body-worn devices, and other accessories through hands-on development work and leadership of external development and manufacturing partners.

  • Act as a subject matter expert for injection moulding design and process development for re-engineering prototype designs and pursing industrial designs early in the development cycle.

  • Collaborate on Agile teams cross-functionally with Product Management, Program Management, System Architect/Engineering, Electrical Engineering, Clinical, Regulatory, Quality, Operations, Human Factors Engineering, and Marketing.

  • Perform functional analysis, create feasibility concepts, and mechanical designs that meet requirements.

  • Lead mechanical responsibilities for risk management (DFMEA) and Design Input Requirements for assigned products and/or subassemblies.

  • Perform structural analysis, detailed tolerance stack and close clearance analysis.

  • Employs DRM (Design for Reliability and Manufacturing) tool sets, to include concept engineering, modelling and analysis, sensitivity studies, stress analysis, DFMA (Design for Manufacturing and Assembly), DFT (Design for Test) and other relevant skills.

  • Work on manufacturing process development, including documentation (DMR), process feasability (CPK/PPK), process qualification (IQ/OQ/PQ), incoming inspections, and PFMEA.

  • Work closely with Quality and Regulatory, e.g., on supplier audits, CAPAs follow up, Nonconforming materials, etc.

About you

  • Bachelor’s, master’s, or PhD degree in mechanical engineering or equivalent.

  • Relevant industry experience in medical devices or other high-tech fields (aerospace, defense, nuclear, wearables, etc.).

  • Experience with manufacturing techniques relevant for complex electromechanical devices, including laser welding, casting, over-moulding, injection moulding, electronics packaging, within a full array of materials.

  • Demonstrated product development and design verification and validation testing to IEC 60601 and ISO 14708 standards or other similar highly regulated industry relevant international and/or company standards (IEC, ASTM, AAMI, ISO, etc).

  • Solid mechanical design experience, with hands on experience in relevant 2D/3D CAD design and mechanical FEM modelling tools.

  • Capable and comfortable with working in a strictly regulated environment, where product development is subject to internal and international quality system standards applicable to medical device development.

  • A team player who collaborates well with other engineers with varying levels of experience.

  • Results oriented, hands-on and thrives well in an innovative, fast-paced and performance driven organization. Self-driver is a must.

  • Solid understanding & experience of Agile Hardware development.

  • Good understanding of System Risk Management and the principles of Design for Manufacturing, Assembly and Testing.

  • Ability to work in a matrixed and geographically diverse business environment.

    Supervision

    Individual contributor, reporting to the Mechanical Engineering Lead.

Apply for the job

Do you want to join our team as our new Senior Mechanical Engineer? Then we'd love to hear about you!