Senior Engineer, NPD Quality

Innovation starts from the Lifesciences is the leading global structural heart innovation company driven by a passion to improve patient lives. With millions of patients served in over 100 countries each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer NPD Quality position is a unique career opportunity that could be your next step toward an exciting future.

Imagine how your ideas and expertise can change a patients life. Our New Product Development Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. Youll partner crossfunctionally with Manufacturing Clinical Regulatory and R&D teams delivering thoughtful solutions to complex challenges while developing your knowledge of the medical device industry.

You Will Make an Impact By:

• Developing updating and maintaining design control documentation throughout product development processes and supporting the creation of design requirement documentation.

• Developing updating and maintaining the technical content of risk management and usability files.

• Collaborating with R&D Manufacturing and crossfunctional stakeholders to drive process and test method development product builds clinical programs design transfer and product launch; participating in design verification and validation testing.

• Investigating complex product quality and compliance issues (e.g. precommercial complaints CAPA nonconformances audit observations PRAs) during new product development; analyzing results making recommendations and developing reports.

• Identifying and optimizing complex Manufacturing and/or R&D processes using engineering methods (e.g. Six Sigma Lean) to support design for manufacturing and continuous improvement; identifying opportunities to redesign or design equipment tools and fixtures to improve manufacturing processes test methods and reduce risk.

• Assigning support tasks; providing instructions to technicians on test execution; training technicians and offering feedback; and coordinating technician work. Also training coaching and guiding lowerlevel employees on routine procedures.

• Performing other incidental duties as assigned by Leadership.

What Youll Need (Required):

• Bachelors Degree in Engineering or a Scientific field with 4 years of related industry experience; OR

• Masters Degree or equivalent in Engineering or a Scientific field with 3 years of related industry experience; OR

• Ph.D. or equivalent in Engineering or a Scientific field with industry or industry/education experience.

What Else We Look For (Preferred):

• Proven expertise using the MS Office Suite including MS Project; CAD experience preferred (as applicable).

• Strong documentation written and verbal communication and interpersonal/consultative relationshipbuilding skills.

• Basic understanding of statistical techniques.

• Previous experience working with lab or industrial equipment (as applicable).

• Substantial understanding of engineering principles theories and concepts.

• Strong problemsolving organizational analytical and criticalthinking skills.

• Solid understanding of processes and equipment used in assigned work.

• Strong leadership skills with the ability to influence change.

• Knowledge of applicable FDA regulations for the medical device industry.

• High attention to detail.

• Ability to interact professionally with all organizational levels.

• Ability to manage competing priorities in a fastpaced environment.

• Ability to work effectively in a team environment including interdepartmental teams and serve as a key contact representing the organization on contracts or projects.

• Commitment to adhering to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and taking appropriate measures to prevent injuries and protect the environment within ones area of influence.

Aligning our overall business objectives with performance 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.

For California the base pay range for this position is $108000 - $153000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.