Product Engineer II

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

The product engineering II supports sustaining engineering activities for stapling products in the Released Product Engineering (RPE) group within the CSI. 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.Within the RPE group, this role focuses on sustaining engineering for commercially released products, including Open, Laparoscopic stapling devices and GYN products. 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 North Haven, CT 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.

Responsibilities may include the following and other duties may be assigned.

• Represents the organization in providing imaginative, thorough, practical solutions to difficult technical issues associated with specific products that are consistent with the organizations objectives.
• Anticipates and identifies problems of a unique and challenging nature, including those requiring research and/or analysis to identify.
• Work on highly complex technical problems and provide solutions that are highly innovative and ingenious to a broad range of problems.
• Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Reviews and evaluates development protocols, results and conclusions.
• Demonstrates an understanding of functional and customer requirements.
• Collaborates with peers to develop appropriate testing to verify product meets requirements and sets appropriate specifications to ensure product reliability and manufacturability.
• Investigates customer complaints on existing products and helps to determine root cause of complaint and corrective actions if necessary.
• Incorporates required regulatory standards in developmental and/or sustaining engineering projects.
• Contributes inventions, new designs and techniques associated with the completion of specific projects.
• Provides primary technical contributions and or may lead sub projects.
• Adheres to safety policy and procedures.

• Conducts project management tasks and documentation with design controls and risk analysis in accordance with established SOPs.
• Prepares reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, and customers.

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

• BS in Engineering
• Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP
• Experience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis
• Process V&V, IQ, OQ, PQ and TMV
• Knowledge of DFMEA and PFMEA, process mapping and critical to quality reviews
• Demonstrated knowledge DFA/DFM, design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&T
• PTC Creo or Solidworks
• CAPA, root cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts
• Experience or knowledge of engineering drawings and GD&T
• Traveling maybe required-up 10%.

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.