Senior Mechanical Engineer

At ONWARD we're looking for a Senior Mechanical Engineer to join our team.

About the job

ONWARD Medical is hiring a Senior (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 design and sustaining support of implantable spinal cord stimulation devices and subsystems, tests methods, and test fixtures. Further, you will be responsible for technical supplier and project management for related projects.

Responsibilities

Serve as the Subject Matter Expert (SME) on materials and manufacturing processes specific to active implantable medical devices (AIMDs).

Ensure compliance with and drive certification to standards applicable to AIMDs, such as ISO 11607-1 & -2, ISO 11737-1 &-3, ISO 11135, AAMI ST72, ISO 10993, EN 45502, and ISO 13485.

Lead technical supplier management and oversee project execution for designated product(s).

Create feasibility concepts, designs, and processes that meet requirements.

Lead Design Verification and Process Validation activities for assigned product(s).

Perform structural, materials science, service/shelf-life, sensitivity, stress, detailed tolerance stack, and close-clearance analyses through computer simulations and bench testing.

Employ DRM (Design for Reliability and Manufacturing) tool sets, DFMA (Design for Manufacturing and Assembly), DFT (Design for Test) and other relevant skills.

Develop Manufacturing process including documentation (DMR), process feasibility (CPK/PPK), process qualification (IQ/OQ/PQ), and incoming inspections.

Manage Risk management (DFMEA/PFMEA) and Design Input Requirements for assigned products and systems.

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

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 sterile implantable and/or surgical medical devices.

Experience with manufacturing techniques relevant for complex electromechanical medical devices, including welding, casting, molding, bonding, machining, and extrusion.

Experience developing and certifying products compliant to ISO 14708 standards or other similar highly regulated industry relevant international and/or company standards (ISO, ASTM, AAMI, IEC, 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 quality system standards such as ISO 13485.

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.

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.

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!