Senior Mechanical Engineer Job in Bellingham 02019, Massachusetts Us
Title: Sr. Mechanical Engineer
Major Job Responsibilities:
As a Senior Mechanical Engineer, the successful candidate will collaborate with research scientists and a cross functional engineering team for the development of a new generation of products. He or she will conceive, design, and bring into production products that define the industry. As a key member of Product Development technical staff, the Senior Mechanical Engineer is expected to proactively provide innovative technical solutions based on extensive knowledge and experience of Mechanical Engineering specifically around skin interface instruments, electromechanical assemblies, control mechanisms, and materials/processes. Responsibilities will include 3D modeling of design, performing design reviews, generating mechanical design specifications and interfacing with outside design partners. The successful candidate will implement product designs for performance, innovation, reliability, and cost.
This position reports to the VP Product Development
Responsibilities:
- Responsible for the integration of a biosensor and skin preparation unit with the electronic and surrounding housings
- Actively involved in supporting clinical research activities
- CAD Drafting/3-D Solid Modeling utilizing Solid Work, AutoCAD, PRO-E or equivalent
- 3-D CAD modeling design of parts or assemblies
- Perform finite element and structural Analysis
- Document mechanical design requirements and specifications of new products
- Perform and document Technical design reviews
- Generate creative ideas and execution of product development for new products
- Read and interpret customer design requirements and ensure mechanical compliance to requirements
- Qualify and monitor component and custom part vendors
- Write Design test plans, conduct testing and document reports
- Coordinate mechanical design activities between the biosensor research and external design teams
- Provide sustaining support of products and improvements post market release
- Support customer complaints investigation by performing root cause analysis
Qualifications:
- Bachelors Degree in Mechanical Engineering. Master degree is preferred
- Experience working with complex medical or diagnostic instrumentation (Software, hardware, chemistry…). Class 3/PMA product experience desirable.
- Demonstrated knowledge of regulated industries including experience with the FDA QSR, ISO 13485:2003 is required.
- Experience in Design for manufacturing (DFM analysis)
- Prior experience with instruments design meeting biocompatibility and sterility specifications is preferred
- Proven track record using a variety of design tools and prototyping techniques to develop successful products that pass worldwide compliance requirements (FCC, CE, Safety, Environmental, etc.)
- Strong technical skills with experience in design and process validations and verification activities
- Problem solving techniques including root cause, cause and effect, and statistical analysis
- Excellent written and verbal skills
- The ability to define problems, collect and use data to establish facts and draw conclusions
- Ability to work independently (and w/ others) and thrive in a startup environment
- Strong desire for hands-on and practical approaches
- Ability to coordinate and lead internal and external design resources.
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