Mechanical Designer

Working Hours: 08:30am - 06:00pm (Mon-Fri)

What You'll Do

. Lead end-to-end product development from concept through commercialization, with strong involvement in NPI and design transfer activities

. Translate user needs and product requirements into practical, manufacturable designs

. Work closely with manufacturing teams on injection molding and assembly processes for DFM/DFA considerations

. Work closely with the QA team to ensure compliance with quality and regulatory requirements (e.g., design controls, documentation, risk management)

. Liaise with customers, vendors, suppliers, and external partners to ensure alignment and timely delivery

. Drive design execution, managing timelines, technical risks, and deliverables while coordinating cross-functional teams

. Support design transfer, including pilot builds, design verification, and design refinement to ensure production readiness

What We're Looking For

. Degree in Mechanical Engineering, Product Design, or related field

. Experience with Siemens NX and/or SolidWorks

. Experience in medical device product development and manufacturing

. Strong understanding of injection molding, assembly processes, and manufacturing constraints

. Experience in verification and validation (V&V) testing and documentation

. Ability to manage projects and communicate effectively with internal and external stakeholders

. Hands-on, detail-oriented, and comfortable working in a fast-paced environment

Nice to Have

. Exposure to electrical, software, or firmware systems, with the ability to support basic testing and troubleshooting

. Exposure to product testing and data analysis to support verification and validation activities, including test method development

. Familiar with medical device regulatory requirements, including ISO 13485, FDA design controls, and IEC product testing standards (e.g., safety and performance testing)

. Experience working with cross-functional or multidisciplinary teams

Why Join Us

. Opportunity to work on meaningful medical devices that impact real users

. End-to-end involvement-from concept to production