R&D Engineer II
About The Position
The R&D Engineer II supports sustaining engineering activities for released cardiovascular surgery products in the Released Product Engineering (RPE) group within the CardioVascular Surgery (CVS) operating unit. This role is responsible for evaluating and implementing product and process changes, developing design and test documentation, supporting investigations, and collaborating across functions to resolve product, supplier, and manufacturing issues while maintaining compliance with medical device regulations and design control requirements. The CVS unit develops and supports a portfolio of devices used in cardiac surgery and cardiopulmonary bypass procedures. Within the RPE group, this role focuses on sustaining engineering for commercially released products, including cardiopulmonary bypass disposables, ablation devices, cannulas, and Off-Pump Coronary Artery Bypass (OPCAB) devices. The team partners closely with Manufacturing, Quality, Regulatory Affairs, and suppliers to maintain product performance, quality, compliance, and continuity of supply throughout the product lifecycle. This position is based in Brooklyn Park, Minnesota and follows a hybrid work model requiring on-site presence four days per week. Travel is expected to be minimal and may include visits to manufacturing sites or suppliers as needed.
Requirements
- Requires a Baccalaureate degree AND minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- U.S. work authorization is required for this position.
Nice To Haves
- Experience with DFMECA and risk analysis methodologies
- Proficiency in statistical analysis tools and methods including Minitab, ANOVA, GR&R, DOE
- Experience with CAD software, including SolidWorks and Creo
- Prior experience in the medical device industry, with working knowledge of FDA 21 CFR Part 803, ISO 13485
Responsibilities
- Develop and implement design solutions for released Class II and Class III medical devices and accessories
- Create and maintain design requirements, specifications, test methods, protocols, reports, and design control documentation
- Evaluate product changes and assess impacts to performance, reliability, manufacturability, regulatory compliance, and cost
- Support investigations related to product issues, supplier nonconformances, manufacturing events, and quality concerns
- Plan and execute verification testing to confirm designs meet established requirements and performance criteria
- Apply statistical methods and engineering analysis to support technical decisions, root cause investigations, and continuous improvement initiatives
- Partner with Manufacturing, Quality, Regulatory Affairs, and suppliers to resolve design and production challenges
- Manage assigned project activities, deliverables, and timelines to support ongoing product sustainment
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
