Senior Mechanical Engineer
On-siteApex, North Carolina, United States
Job Summary
Lead prototyping of compact, wearable systems involving electronic components, rigid-flex PCBs, batteries, RF protection, and biocompatible skin interfacing materials. Coordinate task management among mechanical team members while mentoring junior and mid-level engineers and supporting hiring processes. Design system protections for water ingress to hundreds of feet and corrosion resistance from salt spray, then identify and qualify domestic and international manufacturing sources for scale. Translate user needs and functional requirements into specific design implementations, check prototype accuracy against design intent, and design test fixtures and molds for validation. Provide on-site and remote support for stage-gated device test milestones.
Required Qualifications
- B.S. or M.S. in Mechanical or Biomedical Engineering or a related field
- Eight or more years industry experience in design for wearable monitoring systems or medical devices
- Significant capability with Solidworks for designing rigid or flexible enclosures, molds, test fixtures, and optical interfaces
- Strong knowledge of safety, performance, and regulatory compliance requirements of medical devices, such as IEC 60601, ISO 10993, ISO 13485, ISO 14971, IEC 62366, and related FDA guidance
- Experience in scaling up prototypes toward production
- Experience with rapid prototyping processes, including creating fixtures, molds, and prototype subassemblies
- Familiarity with Design for Manufacturing (DFM), Assembly (DFA), and Test (DFT) practices
Desired Qualifications
- Experience designing waterproof and corrosion-resistant products
- Design experience with systems interfacing with the human body
- Experience working with medical-grade, skin-contacting adhesives, silicones, and foams
- Experience with human factor / usability engineering
- Experience developing and iterating on industrial design concepts for manufactured systems
- Prior experience working with startups and with a local network
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