Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
The Design Quality Engineering Manager leads a team utilizing Design Quality Engineering, and Risk Management techniques and expertise to provide management and functional support for the entire life cycle of Abiomed products. This position also supports company compliance with applicable federal, industry, and corporate procedures, guidelines, and regulations during the design, development, test, manufacture, and distribution of products for US and ROW.
Primary Duties and Responsibilities:
- Define and communicate overall objectives for your team.
- Provide input and leadership for Quality policies, approaches, and standard practices.
- Support maintaining alignment with US and International regulations and standards, as well as Abiomed quality systems.
- Develop, implement, and improve new and existing product and process quality related requirements.
- Identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), EU MDR, ISO 13485, etc.
- Lead Design Quality team in product development, including design control and risk management.
- Lead cross-functional teams to perform and maintain risk assessments.
- Manage long and short-term planning for the Design Quality Engineering team, including training, development, and goal setting.
- Design and implement process improvements for the Design Quality Engineering function, including design controls, risk management, problem solving, root cause analysis and the application of statistical methods.
- Ensure robust processes are employed in new product development.
- Bachelor’s degree in sciences or engineering required with minimum 8 years in quality desired including at least 2 years in a leadership role
- Class III or II medical device background required
- Cardiovascular medical device experience preferred
- ASQ certifications in CQE or CSSBB a plus
- Experience with Domestic and International regulatory requirements and regulating bodies
- Demonstrated application of statistical technique skills and engineering mindset
- Working knowledge and practical application of CFR Part 820, FDA GMP/GLP, MDD, ISO, AAMI and CEN
- Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
- Strong organization, speaking skills, and influential management ability.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a geographically diverse team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to travel approximately 10%, including internationally.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.