Senior Quality Engineer, New Product Development

Edwards Lifesciences • Fannettsburg, PA

262d • $106,000 - $149,000

About The Position

This Senior Quality Engineer - NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.

Requirements

• Bachelor's Degree in Engineering or Scientific field with a minimum of four (4) years related experience; OR a Master's Degree in Engineering or Scientific field with a minimum of three (3) years related experience; OR a PhD in Engineering or Scientific field with no experience or internship/co-op experience.
• Knowledge of and experience with design control, risk management/usability engineering within medical device industry or other regulated industries.
• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements).

Nice To Haves

• Current or prior experience within Medical Device industry.
• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation.
• New Product Development experience from initial concept to commercialization (Class III preferred).
• Experience with Risk Management and Design Control.
• Proven expertise in usage of MS Office Suite including MS Project.
• Basic understanding of statistical techniques.
• Strong problem-solving, organizational, analytical and critical thinking skills.
• Experience in people leadership including direct line reporting responsibilities.
• Quality Engineering experience in New Product Development is preferred.
• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
• Ability to prioritize, plan, and evaluate deliverables to established strategic goals.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects.
• ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus.

Responsibilities

• Providing technical leadership for successful new product development projects by applying design control and risk management principles.
• Partner and collaborate with cross-functional stakeholders and peers on new product development teams.
• Lead development and drive updates to risk management files for new products.
• Lead test method development and validation activities for new designs.
• Lead failure investigations for product failures in design testing and clinical use.
• Lead development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies.
• Develop technical solutions to complex problems, recommend and implement corrective actions.
• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
• Managing/overseeing the work of an assigned team of direct reports within own function.
• Developing a robust talent development plan in alignment with functional growth strategies.
• Ensure compliance with all Federal, State, local and company regulations, policies and procedures.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree