Job Title: R&D Engineer II
Type: Contract - 12 Months
Pay: CAN BE FLEXIBLE
Location: Brooklyn Park, MN
Can you please confirm the 3 main responsibilities/day to day activities required for this role? The primary responsibility for this role will be 2D and 3D modeling of components and finished goods within our Cardiac Surgery product portfolio. This could include updates to existing parts or modeling new parts from scratch. This position will also help troubleshoot design issues and implement improvements while meeting our design and quality system requirements. This includes understanding product requirements and how those translate into design specifications. This role will also create design protocols and reports to validate design changes.
Areas of responsibilities will include mechanical design, injection molding design and troubleshooting, design requirements, test requirements and test procedures. Candidates must be able to translate design inputs, 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.
Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business.
· Work with cross functional teams to review, assess and implement design input for injection molded components.
· Ability to troubleshoot design issues, particularly understand injection molding related issues (i.e., process, material, design intent).
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.
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 Creo, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R&R, attribute agreement analysis, ANOVA, t-test, and regression analysis.

TECHNICAL SKILLS

Must Have
3D Computer Aided Design (CAD)
GD&T knowledge
Nice To Have
Design experience
Injection Molding
Medical Device Experience
Statistical Tools
Can you please confirm your top 3 skills sets required? Experience with 3D CAD modeling software is required (preferably Creo), experience with troubleshooting design issues is preferred, experience with writing design validation/verification protocols and reports is preferred.
What products (if any) will this role support? This role will support our Cardiac Surgery product portfolio, with a focus on our injection molded products.
What is your target years of experience? 2-10 years
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Job Types: Full-time, Contract
Pay: $38.00 - $60.00 per hour

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Ability to Commute:

• Minneapolis, MN 55428 (Required)

Work Location: In perso

Please refer the Job description for details