PRODUCT DEVELOPMENT ENGINEER
Under the supervision of the Director of Engineering, the Product Development Engineer will be responsible for the conceptual development, detailed design, prototype fabrication, and verification of novel medical devices, fixturing, and tooling.
The Product Development Engineer responsibilities will include, but are not limited to, the following:
- Establish design specifications to meet overall device requirements.
- Initiate and develop relationships with 3rd party vendors, contractors and manufacturers.
- Verification testing of designs, from concept to finished product.
- Prototype development (fine-scale assemblies, micro-machining, model building).
- Documentation development that includes (but is not limited to) engineering drawings, specifications, protocols, test reports, work instructions, and quality inspections.
- Planning and periodic reporting of activities and progress.
- Managing projects.
The ideal candidate should have:
- Bachelors Degree in Mechanical Engineering. Biomedical specialization is a plus.
- A minimum of 3 years in the medical device industry or equivalent.
- Very strong design skills using parametric modeling software (Solidworks)
- Experience in structural-heart (specifically mitral valves) related medical devices is considered a very strong asset.
- Start-up experience (working in a fast-paced environment) is a plus.
- Familiarity with design and testing requirements of medical devices (ISO 13485, ISO 5840, ISO 5910).
- Machine shop experience, experience with CNC machines, lathes, drills, grinders, etc.
- Experience in medical device assembly and sewing techniques is a plus.
- Excellent technical writing skills, and strong ability to understand and analyze technical documents.
- Excellent problem-solving skills, with a high level of attention to detail.
- Must be able to work with minimal supervision in a multi-disciplinary team environment (self-motivated, able to self-manage, strong desire to succeed).
- Strong CAD/design skills and mechanical aptitude.
- Familiarity with sewing techniques and product integration.
- Good interpersonal skills including: maturity, respect, courtesy, tact, discretion.
- Must be able to operate under changing priorities and requirements.
How to apply
Email a cover letter and CV to firstname.lastname@example.org.
We'll contact you if we see a fit. Thank you for taking the time to apply.
Vesalius Cardiovascular Inc, 2016