Manufacturing Engineer (All Levels), New Product Development

Advita Ortho; Gainesville (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device company in Gainesville, FL is seeking a New Product Development Engineer to represent manufacturing engineering during product development. The role involves leading design for manufacturability initiatives, ensuring timely completion of manufacturing processes, and collaborating with quality and supply chain teams. Candidates must possess a Bachelor's degree in Engineering and experience in regulated environments, particularly in medical device manufacturing. The position offers full-time employment with opportunities for professional growth.

Qualifications

• 5+ years of experience in manufacturing engineering.
• Experience in regulated environments like medical devices or aerospace.
• Proven application of DFM/DFA principles.

Responsibilities

• Act as manufacturing engineering representative on project teams.
• Ensure timely compliance of manufacturing-related deliverables.
• Support process validation activities in collaboration with Quality Engineering.

Skills

Strong understanding of manufacturing processes

Cross-functional collaboration

Ability to interpret engineering drawings

Knowledge of quality systems

Experience with risk management tools

Education

Bachelor’s degree in Engineering

Tools

CAD viewers

ERP/MRP systems

Document control systems

Job description

New Product Development Engineer

Department: Manufacturing Engineering

Employment Type: Full Time

Location: Gainesville, FL

Description

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 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

• 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).