Engineer II, New Product Development

• Drive manufacturing design control for new products and processes ensuring robust compliant maturation from early builds through commercialization.

• Translate product design into scalable repeatable manufacturing solutions by applying manufacturing engineering principles Edwards systems and operational standards.

• Own and develop manufacturing documentation across the product lifecycle including drawings routers SOPs pFMEAs work instructions and training materials to enable seamless knowledge transfer to production.

• Partner with R&D Quality Pilot and Operations to define and refine processes during QST preDV DV and early buildssupporting root cause investigations and design-for-manufacturability improvements prior to commercialization.

• Develop and execute process characterization experiments and test protocols to establish process understanding capability and control.

• Support and execute manufacturing qualifications and validations (IQ OQ Software) to ensure processes meet regulatory quality and business requirements.

• Influence product and process specifications from an operations perspective including DFx tolerancing materials selection and automation while establishing stability metrics and proactively mitigating risk through SCRR MRR and related forums.

• Serve as the Voice of the Factory leveraging SME product and process knowledge to identify gaps elevate risks and drive continuous improvement.

• Collaborate on manufacturing equipment and tooling development including concept input design refinement and readiness for production use.

• Support manufacturing and compliance issue resolution including CAPA nonconformances audit observations and process transfer activities.

• Identify and implement improvements to processes equipment tools and fixtures using engineering problemsolving approaches LEAN principles and basic statistical methods.

• Execute project deliverables to plan leveraging project management tools such as schedules risk analyses and action tracking to meet customer and program expectations.

• Provide technical leadership on the factory floor including guiding technicians and junior engineers overseeing test execution delivering training and providing realtime feedback.

• Perform additional responsibilities as needed to support program success and business priorities.

What else we look for (Preferred)

• Strong foundation in engineering principles and problem solving with the ability to apply theory to realworld manufacturing and product development challenges.

• Demonstrated experience working with lab or industrial equipment (as applicable) including handson interaction with manufacturing processes test setups and tooling.

• Working knowledge of medical device regulations and quality systems including FDA requirements and Edwards Environmental Health & Safety (EHS) and Quality standards for cleanroom manufacturing.

• Proficiency with engineering and productivity tools including MS Office (Excel Word PowerPoint) and MS Project; CAD experience preferred where applicable.

• Solid understanding of manufacturing processes and equipment with the ability to identify risks opportunities and improvement areas across assigned workstreams.

• Basic understanding of statistical techniques used for process characterization capability evaluation and datadriven decision making.

• Strong documentation and communication skills both written and verbal with the ability to clearly convey technical information to diverse audiences.

• Ability to collaborate effectively across functions and externally including working with vendors suppliers and project stakeholders.

• Proven ability to manage multiple priorities in a fastpaced environment maintaining focus organization and followthrough.

• High attention to detail and commitment to quality particularly in regulated environments where accuracy and traceability are critical.

• Professional presence and interpersonal effectiveness with the ability to interact confidently at all organizational levels.

• Teamoriented mindset with the ability to build productive working relationships and contribute to shared project outcomes.

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