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Associate Director, US NPI and Lifecycle Engineering

Auris Health

Auris Health

United States
Posted on Wednesday, July 12, 2023
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Description

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!

We are seeking a talented and experienced Leader of US NPI and Lifecycle Engineering to join our team and support the development and commercialization of new products as well as the ongoing support of existing product lines.

The Associate Director, US NPI and Lifecycle Engineering , will be responsible for leading a team of managers, engineers and technicians across multiple functions, including new product introduction, sustaining engineering, manufacturing engineering and support. S/he will work closely with cross-functional teams, including R&D, marketing, quality, regulatory, and operations, to ensure successful product development and commercialization.

Key Responsibilities:

• Support the development and commercialization of new products, including contributing to product requirements, developing project plans, and supporting cross-functional teams to meet project timelines and deliverables.

• Develop and implement product lifecycle management strategies to ensure successful product performance throughout the product lifecycle.

• Support continuous improvement initiatives to optimize product design, quality, and cost, and ensure compliance with regulatory requirements.

• Develop and maintain strong relationships with internal and external stakeholders, including customers, suppliers, and key opinion leaders.

• Lead and develop a team of technical managers engineers, and technicians, providing guidance and mentorship to ensure team members reach their full potential.

• Contribute to the development of budgets, timelines, and resource allocation plans for the NPI and Lifecycle Engineering function.

• Lead efforts to refine and/or develop business processes for best in class predictability around product launches

• Experience with process improvement methodologies such as Six Sigma or Lean is a plus

• Familiarity with medical device regulations and quality standards, such as FDA guidelines, ISO 13485, and European Medical Device Regulation (MDR).

Qualifications

• Bachelor’s degree in engineering or related field. A master’s degree is preferred

• 10+ years of experience in engineering roles, preferably in the manufacturing engineering space

• Experience in commercializing products in a regulated environment;

• Experience working in medical device industry is highly preferred

• Strong leadership skills, with experience managing teams across multiple functions with a minimum of 5 years of formal management experience

• Excellent project management skills, with experience managing complex, cross-functional projects.

• Experience with product lifecycle management and sustaining engineering.

• Strong technical background, with a deep understanding of product design and engineering principles.

• Excellent communication and interpersonal skills, with the ability to build relationships with internal and external stakeholders.

• Strong problem-solving skills, with the ability to think creatively and develop innovative solutions.

• We are seeking a talented and experienced Leader of US NPI and Lifecycle Engineering to join our team and support the development and commercialization of new products as well as the ongoing support of existing product lines.

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, sex, 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.