6-12 Month Contract
- BS degree in mechanical or biomedical engineering with a device design and sustaining focus
- Technical writing in support of design inputs, design outputs, qualification activities, regulatory requirements and related pursuits
- Test method development and execution
- Participation in project team collaboration with primary focus on mechanical design and production transfer activities
- Participation in device design reviews as project leader, participant, and independent reviewer, as applicable
- Manufacturing and production support at Company and partner locations
- Support development of engineering lab capabilities (equipment, processes, etc.) to support device development activities
- Working knowledge of standards - UL, IEC, ISO 13485 and related quality system requirements for medical devices
- Strong understanding of BOM creation/definition, change control process, and general documentation standards
- Bachelors and/or Master’s degree in a mechanical engineering or biomedical device discipline, preferably educational discipline in mechanical engineering, and/or biomedical engineering.
Qualifications and Skills
- 8+ years in a lead mechanical engineering capacity for devices with a focus on high quality and attention to detail
- 8+ years of industry experience in product development, including prior experience in a medical device development or medical device manufacturing environment, and development or sustaining engineering role under a regulated quality system
- Demonstrated multiple product/device history of high-yield volume production
- Prior experience with wearable medical devices, designed to operate in an indoor/outdoor environment with multi-sensor wireless communication technologies.
- Proficient in mechanical design for a variety of manufacturing processes; including injection molding, compression molding, thermoforming, CNC machining, die-cutting, and sheet metal stamping/forming
- Excellent design, collaboration and problem solving skills with cross-functional teams.
- Ability to communicate effectively orally and in writing with internal and external customers. Ability to document and articulate mechanical designs a must.
- Proficient in 3D CAD design software, including complex surfacing (SolidWorks preferred.)
- Proficient in Microsoft Office (Word, Excel, Visio, and Outlook)
- Experienced in the use of lab measurement tools (i.e. calipers, gages, etc.)
- Experience with Finite Element Analysis (FEA), Failure Modes and Effects Analysis (FMEA), and Root Cause Analysis (including Pareto, Ishikawa, 5 Why’s, etc.)
- Demonstrated experience in rapid prototyping (i.e. 3D printing, SLA, SLS, machining, etc.)
- Ability to inspire and influence change collaboratively
- Proven ability to work independently given high-level direction
- Knowledge of product development methodologies and best practices
- Excellent requirements, specification, test plan/report writing skills
- Exposure to LEAN, Agile, SAFe execution methodologies