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SurModics' mission is to exceed our customers' expectations and enhance the well-being of patients by providing the world's foremost, innovative surface modification technologies and in vitro diagnostic components.
The Process Engineer is responsible for developing and characterizing manufacturing processes in support of the development of novel medical devices, surface modification technologies, and combination products.
ESSENTIAL JOB FUNCTIONS:
- Develop coating and manufacturing processes to meet internal or external customer requirements. Identify key process factors and characterize the design space.
- Conduct analysis of experimental results utilizing appropriate statistical tools
- Implement process control strategies and support the successful execution of process validation studies
- Support the design and build of new process equipment to enable scale-up and robust manufacturing
- Effectively communicate experimental results and conclusions to key stakeholders. Produce documentation consistent with SurModics’ quality system standards and best practices for regulated products.
- Actively contribute to cross-functional product development teams. Add value through leadership and product development experience.
ADDITIONAL JOB FUNCTIONS:
- Provide technical leadership and mentorship to engineering staff. Provide technical guidance and advise management on new technology and opportunities.
- Actively contribute to SurModics IP portfolio and perform technical work in a manner consistent with SurModics notebook and IP policies.
- Attend technical meetings, seminars, trade shows, etc. and review relevant literature as required to maintain and expand technical proficiency.
REQUIRED SKILLS AND EXPERIENCE:
- BS or advanced degree in engineering
- 10+ years process engineering experience
- 5+ years experience in medical device product development
- Demonstrated skills in process characterization and manufacturing process scale-up
- Demonstrated command of process control strategies and process validation
- Excellent written communication skills
- Strong verbal communication skills and ability to work effectively in a team environment
ADDITIONAL SKILLS AND EXPERIENCE:
- Experience working with coatings, reagents, or other chemical components
- Strong skills in experimental design (DOE) and statistical methods
- Good mechanical aptitude and experience with manufacturing equipment design and build
Interested candidates are encouraged to send an electronic copy of resume and cover letter by clicking Apply now.
SurModics, Inc. is an Equal Opportunity Employer.