Engineering Manager Post Market Quality - NMPH - Rice Creek, MN (Onsite/Hybrid)

$136,000 - $204,000/Yr

Medtronic - Fridley, MN

Full-time - Mid Level

Hybrid - Fridley, MN

Professional, Scientific, and Technical Services

About the position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. In this exciting role as a Post Market Quality Engineering Manager, you will have responsibility for many aspects overseeing product quality and reliability for medical devices that are released as part of the Medtronic Neuromodulation organization. In this role, you will oversee investigation of issues and analysis of risks for products in the field. This includes trends in complaint data, labeling, software, and hardware related issues. You will also provide risk and reliability engineering support for released product design and process changes.

Responsibilities

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Requirements

• Bachelor's degree in engineering or science field with a minimum of 5+ years of experience in quality and/or engineering in the Medical Device or related industry.
• OR advance degree in engineering or science field with 3+ years of experience in quality and/or engineering in the Medical Device or related industry.

Nice-to-haves

• 3+ Years of Engineering Management experience.
• Experience working in a regulated industry (e.g., FDA-regulated).
• Master's Degree in Engineering, Quality, Regulatory, or related.
• Experience in Medical devices - specifically in Neuromodulation devices is preferred.
• Experience with Field Corrective Actions.
• Experience with Software Application or Embedded Software development and testing.
• Experience in medical devices or other highly regulated industry such as defense or automotive.
• Experience in quality, reliability, design assurance, safety, or systems engineering.
• Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.).
• Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
• FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries.
• Ability to multi-task, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
• Experience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams.
• Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships.
• Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude.
• Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
• High degree of initiative and ability to motivate a team.
• Strong attention to detail and accuracy.
• Excellent organization skills: ability to successfully balance and prioritize multiple ongoing projects/tasks.
• Strong analytical skills and the ability to solve problems through analytical reasoning.
• ASQ Certification in Quality or Reliability is a plus.
• Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications is a plus.
• Self-Starter with a sharp focus on quality and customer experience.

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 (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)