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, pre‑DV, DV, and early builds—supporting 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, non‑conformances, audit observations, and process transfer activities.

• Identify and implement improvements to processes, equipment, tools, and fixtures using engineering problem‑solving 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 real‑time 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 real‑world manufacturing and product development challenges.

• Demonstrated experience working with lab or industrial equipment (as applicable), including hands‑on 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 clean‑room 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 data‑driven 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 fast‑paced environment, maintaining focus, organization, and follow‑through.

• 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.

• Team‑oriented 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 one’s scope of influence.