Principal Engineer, Process Development, R&D
Teleflex
full-time
Posted on:
Location Type: Office
Location: Maple Grove • Minnesota • United States
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Salary
💰 $125,700 - $188,600 per year
Job Level
About the role
- Collaborate with Design Development, Product Development, and Manufacturing Engineers to define the design and processes for new products that meet the clinical needs.
- Lead a small team of engineers to define and effectively execute the process development strategy.
- Represent the process development function on the core team through collaboration, strategy, technical knowledge, and communication.
- Manage the planning, execution, and documentation of all process development & validation activities for new products based on projected product volume, project timelines, and COGS targets.
- Actively pursue design, process, and equipment improvements to improve process reliability and minimize product manufacturing cost.
- Make process decisions that minimize process issues and resolve those that occur.
- Specify, design, characterize, optimize, and implement manufacturing processes that are capable of meeting design, quality, productivity, and cost requirements.
- Investigate and troubleshoot process issues, determine causes, and implement solutions.
- Develop and implement easy to follow work instructions to produce products that meet requirements.
- Establish project timelines, track progress, manage to the schedule, and communicate project status to management and project leader.
- Lead generation of product development process documentation (e.g., PFMEAs, characterization studies, protocols, reports, MPs, Design Transfer reports, etc.).
- Plan, coordinate, and execute process validations. Transfer validated processes and equipment into production for commercial manufacturing.
- Coordinate with production to produce initial finished goods inventory for new product launches.
- Perform test data analysis.
- Conduct risk analysis, failure analysis, and root cause investigations and report the results.
- Coordinate and execute product development builds.
- Build partnerships and collaborate with others to meet shared objectives.
- Work effectively in a diverse group, respect different ideas, perspectives, and values.
Requirements
- BA/BS in Engineering or physical sciences required.
- 8 years of related experience required.
- Expert level experience working in medical device catheter process development.
- Expertise in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle
Benefits
- medical, prescription drug, dental and vision insurance
- flexible spending accounts
- participation in 401(k) savings plan
- various paid time off benefits such as PTO, short- and long-term disability and parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process developmentprocess validationdesign transfertest data analysisrisk analysisfailure analysisroot cause investigationmanufacturing process optimizationwork instruction developmentproduct development documentation
Soft Skills
collaborationleadershipcommunicationproject managementproblem-solvingteamworkadaptabilityrespect for diversitystrategic thinkinginterpersonal skills
Certifications
BA/BS in EngineeringBA/BS in physical sciences