Job Title: Principal Sustaining R&D Engineer
Job Location: 3850 Brickway Blvd, Santa Rosa, CA 95403
This is an exciting opportunity to join our clients Structural Heart and Aortic operating unit to work with a passionate team focused on early phase technology strategic exploration, exploratory proof of principle work and product development excellence. The engineer will use their high level technical and leadership skills to advance the development of an innovative product to treat aortic disease.
This position requires strong technical and leadership skills to support commercial produce continuity and our global supply of products designed to treat diseases of the vascular system. The Principal Sustaining R&D Engineer will apply advanced engineering principles, theories, and concepts in working on complex technical problems and will provide technical leadership on post market objectives.,
Responsibilities may include the following, and other duties may be assigned:
- Maintain product design integrity of commercially available products using sound engineering principles while working within appropriate Design Control requirements.
- Ability to manage large projects or processes that span outside of immediate job area.
- Apply problem solving skills, critical thinking, technical principles, and theories to solve complex problems in the field of aortic disease treatment;
- Investigating product design and reliability issues in partnership with other R&D Engineers, Manufacturing Engineers, Quality Engineers, and other cross-functional departments to determine root cause and implement solutions.
- Review and approve change orders of post-market products ensuring design integrity and reliability targets are met.
- Review and approve design and process qualifications.
- Review and approve verification and validation documentation.
- Oversee process development objectives of internal and external partners.
- Develop technical solutions and conduct testing, evaluates results using appropriate statistical analysis tools, and generate test reports;
- Work collaboratively with external suppliers and business partners as well as internal cross-functional team members to maintain post market product continuity.
- Provide technical input supporting submissions to regulatory bodies and governmental agencies;
Must Have: Minimum Requirements
- Bachelor’s degree in engineering (Mechanical, Materials, Chemical or Biomedical)
- Minimum 7 years of experience in the medical device industry or 5 years of experience with MS or PhD degree
Desired/Preferred Qualifications
- High level proficiency of technical principles, theories, and design concepts in the field of medical device design
- Nitinol material and stent processing experience a plus.
- Experience process development and testing a plus.
- Experience in design verification and validation.
- Experience with design and process qualification.
- Excellent written and verbal communication skills;
- Ability to lead large projects from a technical perspective while building a collaborative work environment.
- Ability to work well in a team
Travel Expectations: About 10% of the time
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.