Quality Engineering Manager - New Product Development
BioCT Innovation Commons, California, MO, United States
A Day in the Life
Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineering Manager to join our innovative team located at the North Haven, CT site. This role will be in the surgical operating unit managing the new product development quality team. The ideal candidate will have 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. This position requires a strong team player who is a self‑starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.
Responsibilities
Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
Develops, evaluates, implements and maintains 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.
Participates in cross‑functional development teams, providing mechanical and/or electrical reliability engineering expertise.
Leads and mentors teams in the development, implementation, and maintenance of the reliability processes and standards.
Collaborates with cross‑functional teams to define and implement engineering and statistical processes that ensure product reliability and compliance throughout the product lifecycle.
Ensures compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participates in regulatory audits and inspections.
Leads team in creating and maintaining the risk management file, including the risk management plans and reports, and conducting regular risk reviews.
Must Have: Minimum Requirements
Bachelor’s degree required.
Minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.
For Baccalaureate degrees earned outside the United States, a degree that satisfies 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice to Have
Experience:
Prior people leadership
Certifications:
Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent, 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.
Physical Job Requirements
The above statements describe the general nature and level of work being performed by employees assigned to this position. They are not an exhaustive list of all required responsibilities and skills. The physical demands described within the Responsibilities section represent those that must be met to successfully perform the essential functions. Reasonable accommodations may be made. For office roles: employees are regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers.
U.S. Work Authorization & Sponsorship
At Medtronic, U.S. work authorization sponsorship is offered exclusively for Principal‑level roles and above. Roles below Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Salary ranges for U.S. locations (excl. PR): $140,800.00 – $211,200.00. The position is eligible for the Medtronic Incentive Plan (MIP). Compensation is based on experience, certification, market conditions, and location.
Benefits for regular employees include health, dental and vision insurance, health savings account, healthcare flexible spending account, life insurance, long‑term disability, dependent daycare spending account, tuition assistance, 401(k) with employer match, short‑term disability, paid time off, paid holidays, employee stock purchase plan, employee assistance program, and non‑qualified retirement plan.
About Medtronic
We lead global healthcare technology and boldly address the most challenging health problems. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. Our diverse team, spanning across research, manufacturing, and business, innovates on the factory floor, in the lab, and in the conference room.
EEO Statement
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, genetic information, marital status, public assistance status, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
#J-18808-Ljbffr
Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineering Manager to join our innovative team located at the North Haven, CT site. This role will be in the surgical operating unit managing the new product development quality team. The ideal candidate will have 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. This position requires a strong team player who is a self‑starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.
Responsibilities
Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
Develops, evaluates, implements and maintains 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.
Participates in cross‑functional development teams, providing mechanical and/or electrical reliability engineering expertise.
Leads and mentors teams in the development, implementation, and maintenance of the reliability processes and standards.
Collaborates with cross‑functional teams to define and implement engineering and statistical processes that ensure product reliability and compliance throughout the product lifecycle.
Ensures compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participates in regulatory audits and inspections.
Leads team in creating and maintaining the risk management file, including the risk management plans and reports, and conducting regular risk reviews.
Must Have: Minimum Requirements
Bachelor’s degree required.
Minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.
For Baccalaureate degrees earned outside the United States, a degree that satisfies 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice to Have
Experience:
Prior people leadership
Certifications:
Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent, 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.
Physical Job Requirements
The above statements describe the general nature and level of work being performed by employees assigned to this position. They are not an exhaustive list of all required responsibilities and skills. The physical demands described within the Responsibilities section represent those that must be met to successfully perform the essential functions. Reasonable accommodations may be made. For office roles: employees are regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers.
U.S. Work Authorization & Sponsorship
At Medtronic, U.S. work authorization sponsorship is offered exclusively for Principal‑level roles and above. Roles below Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Salary ranges for U.S. locations (excl. PR): $140,800.00 – $211,200.00. The position is eligible for the Medtronic Incentive Plan (MIP). Compensation is based on experience, certification, market conditions, and location.
Benefits for regular employees include health, dental and vision insurance, health savings account, healthcare flexible spending account, life insurance, long‑term disability, dependent daycare spending account, tuition assistance, 401(k) with employer match, short‑term disability, paid time off, paid holidays, employee stock purchase plan, employee assistance program, and non‑qualified retirement plan.
About Medtronic
We lead global healthcare technology and boldly address the most challenging health problems. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. Our diverse team, spanning across research, manufacturing, and business, innovates on the factory floor, in the lab, and in the conference room.
EEO Statement
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, genetic information, marital status, public assistance status, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
#J-18808-Ljbffr