Quality Engineering Manager - New Product Development

Medtronic•North Haven, CT

23h•Onsite

About The Position

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineering Manager to join their innovative team at the North Haven, CT site. This role is within the surgical operating unit, managing the new product development quality team. The ideal candidate will possess a strong leadership background in Quality New Product Development activities, including reliability science, reliability planning and testing, risk management, product development, design controls, and regulatory compliance within the medical device industry. The position requires a strong team player who is a self-starter, inquisitive, and a fast learner, playing a critical role in developing medical devices and ensuring patient safety throughout the product lifecycle.

Requirements

Bachelor’s degree required
Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

Nice To Haves

Prior people leadership
Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
Industry Experience: Medical device industry.
Technical Skills: Proficient in quality management systems, reliability, risk management, regulatory compliance, and statistics.
Other: Basic knowledge of human anatomy/physiology and surgical procedures.
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.

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.
Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Participate in cross functional development teams, providing mechanical and/or electrical reliability engineering expertise.
Lead and mentor teams in the development, implementation, and maintenance of the reliability processes and standards
Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product reliability and compliance throughout the product lifecycle.
Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.
Leading team in creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.

Benefits

Competitive Salary and flexible Benefits Package
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)
Paid sick time (for temporary employees, as required under applicable state law)