Manufacturing Engineer (All Levels), New Product Development
Advita Ortho
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- Location
- Gainesville, FL
- Work style
- On-site
- Job type
- Full time
- Posted
- Oct 13
- 6 days ago
Career path
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About the company
Advita Ortho
Medical devices · 2 to 10 employees
What you'll do
- Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Industrial, or related field) required
- 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.
- 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).
What you need
- 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.
- Education: a bachelor's degree
Key skills
Design for ManufacturabilityDesign for AssemblyManufacturing processesToolingFixturesProcess validationQuality systemsRegulatory standardsEngineering drawingsGD&TPFMEACAD viewersERP/MRPDocument control systems
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Read the full posting here
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.Key ResponsibilitiesAct 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 ExpertiseEducation: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).