Sr. Quality Engineer, NPD - IHFM

About the role

Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. 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.

Responsibilities

• Provide technical leadership for successful new product development projects by applying design control and risk management principles to influence efforts from concept through product launch, including design verification, validation, and design and manufacturing specification development.
• Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
• Lead development and drive updates to risk management files for new products.
• Lead test method development and validation activities for new designs.
• Lead development and implementation of inspection and testing mechanisms for components, sub-assemblies, and final assemblies used in new product design and manufacturing.
• Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering.
• Collaborate with manufacturing and operations teams to ensure successful transfer and launch of robust products.
• Manage and oversee the work of an assigned team of direct reports within your function.
• Develop a robust talent development plan in alignment with functional growth strategies of the individual and the department.
• Ensure compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Perform other incidental duties as assigned by management.
• Travel up to 20% domestically and internationally.

Requirements

• Bachelor’s Degree in Engineering or Scientific field, with 4 years of experience in industry or a combination of industry and education.
• OR Master’s Degree or equivalent in Engineering or Scientific field, with 3 years of experience in industry or a combination of industry and education.
• OR Ph.D. or equivalent in Engineering or Scientific field with industry experience or a combination of industry and education.

Preferred Qualifications

• Current or prior experience within the 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.
• Working knowledge of domestic and international regulatory requirements for Medical Device regulations.
• Proven expertise in the usage of MS Office Suite, including MS Project.
• Advanced understanding of statistical techniques.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Quality Engineering experience in New Product Development.
• Strong documentation, communication, and interpersonal relationship skills, including negotiating and relationship management.
• 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.

Benefits

We offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

Pay

For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).