The successful candidate will have the opportunity to work with other cross-functional team members and dovetail into all the different elements of taking a product from concept through all the design phases to commercialization. The candidate will also get exposure to sustaining activities that arise on our commercial lines, giving the candidate a wide array of experience and opportunities to grow in their career. Additionally, the candidate will have an opportunity to work with the appropriate government bodies to obtain regulatory approval and to issue patents in conjunction with the IP department.
Impact Through Innovation
- Work on all elements of the Research and development of projects from concept generation through to commercialization.
- Implement cutting-edge technologies to provide the optimum design solution for products.
- Lead the design of concepts and prototypes in advance of selecting the most promising solution to take into Design Freeze.
- Lead the development of plans and testing for design verification and validation.
- Drive the development of intellectual property within the company.
- Provide technical, project-level leadership to junior engineering staff as needed.
- Assist in DFM ( Design for manufacturing) activities.
- Support and lead Research and Development sustaining projects as they arise on commercial production lines.
- Track deliverables from internal and external teams against product design change requirements.
- Be the key central communications point for sustaining related project activity.
- Adhere to all requirements of the Quality Management System.
- Successful completion of a bachelors Engineering degree.
- 5+ years of experience working in an engineering role.
- Knowledge of design requirements as per 21 CFR 820 and ISO 13485.
- Knowledge of risk management as per ISO 14971.
- Experience with drafting and maintaining DHF and DMR documentation.
- Experience with rapid design iteration and making design recommendations.
- Ability to independently develop and adapt work plans based on vague or changing project goals.
- Strong hypothesis-driven experimental design and statistical analysis skills.
- Demonstrated experience in creative engineering design.
- Self-starter with the ability to work independently and within a diverse team of engineers, professional staff, and production staff.
- Superior communication skills (verbal/written) and demonstrated leadership skills.
- Strong interest in biomedical technology.
- Dynamic, flexible approach to work with a results-oriented attitude.
- Excellent SolidWorks skills.
- Experience with all or some of the following laser welding, reflow technologies, crimping technologies, braiding, coiling, laser cutting, injection molding, and adhesive bonding.
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