The Senior Material Engineer role supports pre/post-market engineering by serving as a leader in evaluating and solving material related changes in order to develop and/or improve medical devices and manufacturing processes, and advance the strategic goals of the company.
- Identify and solve department and system-level material problems/issues.
- Contribute technical and scientific expertise in the areas of material evaluation,material design, failure mode analysis and root cause analysis.
- Complete projects consistent with corporate and departmental objectives by engaging the efforts of engineering, regulatory, clinical, non-clinical and contract research organizations.
- Contribute to the intellectual property of the company via invention disclosures and patent applications.
- Develop material characterization studies to define expected performance margin relative to design targets.
- Responsible for reviewing, understanding, and summarizing material characterization testing results.
- Support cross functional teams to achieve company goals.
- Lead and support large scale or multiple engineering projects with a high degree of independence
- Review and, where appropriate, approve, team member documentation
- Act as a mentor to other personnel in the Engineering department.
- Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision
- Must strictly adhere to safety requirements
- Maintain regular and punctual attendance
- Must have effective oral and written communication skills
- Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
- Support material biocompatibility testing initiatives
- PhD in Engineering or Engineering Technology; or
- MS in same or MBA with 3 years relevant experience; or
- BS degree in same with 5 years relevant experience
- Ability to work independently and remain self-motivated.
- Proven problem solving skills.
- Proven leadership abilities
- Proven inter-personal skills
- Excellent written and verbal communication skills.
- Comprehensive knowledge of medical device quality & regulatory systems and medical device directives (i.e.ISO13485 and FDA CFR 820), and EU Medical Device Regulation 2017/745
Physical Requirements/Work Environment
- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
- Good manual dexterity.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
- Approximately 90% of the time is spent in a normal office environment requiring sitting and moving around the building, or in a "clean" environment Production setting requiring protective clothing and safety glasses. No more than 10% of the time is spent in travel to various vendors, testing sites, etc.