Engineering Manager

Job Summary

We are seeking an energetic and detail-oriented Engineering Manager to lead our dynamic engineering team. The Manufacturing Engineering Manager leads all engineering activities that support the production of medical devices and related products in a fast‑moving, small‑company environment. This role combines strategic leadership with hands‑on technical work, ensuring products are manufactured safely, efficiently, and in compliance with FDA, ISO 13485, and ISO 9001 standards. You will influence processes end‑to‑end and collaborate closely with R&D, Quality, Operations, and Supply Chain.

You will lead the plant engineering team—including manufacturing engineering, molding/production technicians, machine shop, continuous improvement, and facilities—and serve as the Company Safety Officer. A major focus will be automating production processes to achieve cost‑reduction and productivity goals.

This position reports to the Plant Leader and is part of both the Plant Leadership Team and the Company’s Extended Leadership Team.

Key Responsibilities

Manufacturing Engineering Leadership

• Own manufacturing engineering, process development, equipment selection, and continuous improvement.
• Build scalable processes for a growing operation.
• Lead root‑cause investigations and corrective actions.
• Oversee extrusion, injection molding, converting, and machine shop operations.
• Drive continuous improvement and cost‑reduction initiatives, including Kaizen.

Process Development & Optimization

• Develop, validate, and document manufacturing processes (IQ/OQ/PQ).
• Implement lean principles to reduce waste and improve throughput.
• Maintain work instructions, process flows, and PFMEAs.

Production Support

• Provide daily technical support to production teams.
• Troubleshoot equipment, tooling, and process issues.
• Train operators and technicians on new processes and equipment.
• Own preventive maintenance programs.

Quality & Regulatory Compliance

• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 9001, and internal QMS.
• Partner with Quality on nonconformances, CAPAs, and risk management.
• Support internal and external audits.

Equipment & Tooling Management

• Specify, procure, install, and maintain production equipment.
• Manage preventive maintenance and calibration activities.
• Coordinate with vendors and internal teams.

Cross‑Functional Collaboration

• Work with R&D on design transfer and new product introduction.
• Support Supply Chain with vendor qualification and manufacturability.
• Partner with Operations on capacity planning and scaling.

Project Management

• Lead engineering projects from concept through implementation.
• Manage timelines, budgets, and resources.
• Communicate project status to leadership.

Facilities & Safety

• Oversee facility maintenance, expansion, and improvement projects.
• Serve as Company Safety Officer; ensure OSHA compliance.
• Lead incident reporting, investigations, training, and safety audits.
• Manage hazardous materials, waste, and wastewater processes.

Leadership & Financial Performance

• Build and develop a high‑performing engineering team.
• Drive year‑over‑year improvements in OTD, productivity, safety, quality, and cost.
• Develop capital plans and manage related reporting.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or related engineering field.
• 7+ years of engineering experience, including 2+ years in leadership.
• Experience with automation projects.
• Strong project management and organizational skills.
• Excellent communication, collaboration, and leadership abilities.
• Proven track record of delivering results.
• CAD proficiency (SolidWorks preferred).
• Proficiency with MS Office, ERP systems, and project management tools (e.g., Asana).

Preferred

• Experience in regulated medical device manufacturing.
• Injection molding and/or extrusion experience.
• Lean Six Sigma certification.
• Experience using AI tools to improve productivity.
• 3D printing experience.

Competencies

• Strong analytical and problem‑solving skills.
• Ability to balance strategic thinking with hands‑on execution.
• Excellent documentation and communication skills.
• Adaptability in a resource‑constrained, fast‑moving environment.
• Demonstrated success in small‑company or startup settings.

Team Structure

Direct reports include engineers, technicians, and machine shop personnel.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance