The Role
Represents Manufacturing Engineering throughout new product development and product transfer. Leads DFM/DFA, defines processes, tooling, fixtures, equipment, and work instructions, supports validation and pilot builds, ensures FDA and ISO compliance, manages manufacturing risks, and collaborates with R&D, Quality, Supply Chain, and Operations to deliver scalable products on schedule.
Summary Generated by Built In
The New Product Development (NPD) Engineer is responsible for representing Manufacturing Engineering throughout the product development lifecycle. This role serves as the voice of manufacturing on cross‑functional project teams and ensures that product designs are manufacturable, scalable, compliant, and released on schedule.
The NPD Engineer partners closely with R&D, Quality, Supply Chain, and Operations to drive design for manufacturability (DFM), ensure timely completion of manufacturing deliverables, and support successful transfer of new products into production in compliance with applicable regulatory and quality system requirements.
The NPD Engineer partners closely with R&D, Quality, Supply Chain, and Operations to drive design for manufacturability (DFM), ensure timely completion of manufacturing deliverables, and support successful transfer of new products into production in compliance with applicable regulatory and quality system requirements.
Key Responsibilities
- Act as the manufacturing engineering representative on new product development and sustaining project teams.
- Lead and influence Design for Manufacturability (DFM) and Design for Assembly (DFA) activities throughout the design lifecycle.
- Review and provide formal manufacturing input on product designs, drawings, specifications, and change orders.
- Ensure all manufacturing-related deliverables are completed accurately, on time, and in alignment with project timelines.
- Define and document manufacturing processes, equipment requirements, tooling, fixtures, and work instructions for new products.
- Support and/or lead process validation activities (IQ/OQ/PQ) in collaboration with Quality Engineering.
- Partner with Quality to ensure compliance with FDA, ISO, and internal Quality System requirements during product development and transfer.
- Identify manufacturing risks early and drive mitigation plans to support robust product launches.
- Support pilot builds, first article builds, and production ramp up activities.
- Collaborate with Supply Chain to support supplier selection, supplier readiness, and manufacturability of purchased components.
- Provide technical support during design reviews, risk assessments (e.g., PFMEA), and change management activities.
- Contribute to continuous improvement initiatives related to manufacturing efficiency, quality, and cost.
- Maintain accurate documentation in accordance with document control and change management procedures.
Skills Knowledge and Expertise
Education:
- Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Industrial, or related field) required
Experience:
- Minimum 1-5 years experience in manufacturing engineering within a regulated environment (medical device, aerospace, automotive, or similar).
- Experience supporting new product development and product transfer to manufacturing.
- Demonstrated experience applying DFM/DFA principles to product designs.
Functional/Technical Knowledge, Skills and Abilities Required:
- Strong understanding of manufacturing processes, tooling, fixtures, and production equipment.
- Working knowledge of quality systems, validation requirements, and regulatory standards (e.g., FDA, ISO).
- Ability to interpret engineering drawings, specifications, and GD&T.
- Strong cross functional collaboration and communication skills.
- Proven ability to manage multiple deliverables and meet project deadlines.
- Experience with risk management tools such as PFMEA preferred.
- Proficiency with standard engineering and documentation tools (e.g., CAD viewers, ERP/MRP, document control systems).
About
At Advita Ortho, everything we do is focused on innovation. Whether creating revolutionary ways to optimize the surgical experience, developing the latest in orthopedic implants and instruments, or using cutting-edge technology to improve efficacy and outcomes. These advancements transform the very experience of mobility and allow you to lead your patients to greater freedom. It’s innovation in every step, every moment, every move.
Skills Required
- Bachelor's degree in Manufacturing, Mechanical, Biomedical, Industrial, or related Engineering field
- 1-5 years of manufacturing engineering experience in a regulated environment
- Experience supporting new product development and product transfer to manufacturing
- Demonstrated experience applying Design for Manufacturability and Design for Assembly principles
- Understanding of manufacturing processes, tooling, fixtures, and production equipment
- Working knowledge of quality systems, validation requirements, FDA, and ISO standards
- Ability to interpret engineering drawings, specifications, and GD&T
- Strong cross-functional collaboration and communication skills
- Ability to manage multiple deliverables and meet project deadlines
- Experience with PFMEA and other risk management tools
- Proficiency with CAD viewers, ERP/MRP, and document control systems
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The Company
What We Do
Advita Ortho is a global medical-device company focused on high-quality orthopedic implants and integrated surgical technologies. Its solutions use data, artificial intelligence, and machine learning to support surgeons and improve patient outcomes. The company’s mission is to empower surgeons with transformative orthopedic innovations that help patients regain mobility, live healthier and more active lives, and improve quality of life worldwide.
