MDR - Sr R/D Engineer - Exempt
7611 Northland Drive North Crystal, MN 55428 US
- Can you please confirm your top 3 skills sets required?
- Mechanical/electrical/biomedical engineering, experience with test methods and report writing, experience with statistical software eg minitab, jmp
- What is your target years of experience?
- 10+ yrs experience
Senior Level mechanical Engineer to join our R&D Released Product Engineering (RPE) Organization. This role will support commercially released products (Sustaining) activities focused on the procedure packs used in cardiopulmonary bypass procedure (CPB).
Areas of responsibilities will include mechanical design, design requirements, test requirements and test procedures. Collaborate with other RPE, Regulatory, Manufacturing and Quality colleagues to ensure product issues, compliance concerns, supplier and manufacturing non-conformities are addressed and cost effective. Candidates must be able to understand design implications to changes, write detailed specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.
A DAY IN THE LIFE
- Design support for procedure pack products for medical applications in a regulated environment.
- Create robust design solutions that address broad development problems involving class II disposable medical devices and accessories.
- Support sustaining engineering programs to support new and existing products to ensure sustainable and stable operations of production. Identify areas that require additional investigation.
- Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business.
- Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
- Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business. Document and support decisions using engineering analysis and data.
- Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements.
- Utilize project management and lean sigma methodologies, including DMAIC and MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices).
- Utilize design development, analysis and statistical tools, to include Pro/E, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R & R, attribute agreement analysis, ANOVA, t-test, and regression analysis.
- Interface with suppliers, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products.
- Create and communicate project plans, tasks and deliverables, and manage time to meet project deadlines.
- Lead troubleshooting and problem-solving efforts related to development projects. Support decisions through thorough engineering analysis and data.
Nice to Have:
- BS or MS in Mechanical Engineering or equivalent with 7+ years progressive mechanical design experience in a regulated medical industry
- Proven communication skills and ability to lead within a multi-functional team environment
- A demonstrated capacity for solving problems through creative designs
- Knowledge and experience using DFMECA FMEA, DOE.
- Knowledge and experience with statistical analysis (Minitab, ANOVA)
- Knowledge of MDR regulations and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices);
- utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s, Ishikawa (Fishbone).
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