Job Summary:
Engineering Manager is responsible for leading the engineering team in the development, transfer, validation, and continuous improvement of medical device manufacturing processes. This position oversees engineering projects from concept through production, manages engineering resources and priorities, supports customer technical needs, and drives operational excellence through process improvement, automation, and cross-functional collaboration. The Engineering Manager leads engineers and engineering technicians while ensuring projects are completed safely, on schedule, within budget, and in compliance with customer and regulatory requirements.
Essential Functions:
1. Engineering Leadership
Lead, mentor, and develop a team of engineers and engineering technicians by establishing priorities, assigning resources, providing technical guidance, conducting performance reviews, and fostering a culture of accountability, collaboration, and continuous improvement.
2. Project Management
Manage multiple engineering projects simultaneously, including new product introductions, product transfers, equipment implementation, process improvements, and manufacturing support. Develop project schedules, allocate resources, manage budgets, identify risks, and ensure milestones are achieved.
3. Manufacturing Process Development
Direct the development, validation, and optimization of manufacturing processes for injection molded and medical device products. Support process capability improvements while ensuring manufacturability, repeatability, and efficiency throughout production.
4. Equipment and Automation
Lead the specification, procurement, installation, qualification, and continuous improvement of manufacturing equipment and automation systems to improve capacity, reduce labor, and increase process reliability.
5. Validation & Regulatory Compliance
Oversee engineering activities supporting IQ, OQ, and PQ validation protocols while ensuring compliance with FDA Quality System Regulations, ISO 13485, customer requirements, and internal quality systems.
6. Customer Technical Support
Serve as the primary engineering contact for customers by participating in technical reviews, project planning, design for manufacturability discussions, validation planning, troubleshooting, and production support throughout the product lifecycle.
7. Continuous Improvement
Identify opportunities to improve safety, quality, delivery, and cost through Lean Manufacturing, Six Sigma, root cause analysis, and process optimization initiatives.
8. Cross-Functional Collaboration
Work closely with Quality, Operations, Production, Supply Chain, Tooling, Maintenance, and Sales to successfully launch products, resolve manufacturing issues, and support strategic business objectives.
9. Engineering Documentation
Ensure engineering documentation including work instructions, validation documentation, engineering change orders, risk assessments, drawings, specifications, and process documentation is complete, accurate, and maintained according to company procedures.
10. Technical Problem Solving
Lead investigations into manufacturing, equipment, and product issues using structured problem-solving methodologies. Implement corrective and preventive actions to improve process capability and product quality.
Competency:
- Knowledge: In-depth understanding of plastics injection moulding processes, tooling design, and manufacturing engineering principles.
- Skills: Strong leadership, project management, and problem-solving skills. Proficiency in CAD software, ERP systems, and other engineering tools.
- Abilities: Ability to manage multiple projects simultaneously, work under pressure, and make data-driven decisions. Excellent communication and interpersonal skills.
Supervisory Responsibilities:
- Direct supervision of engineering and tooling staff, including engineers, engineering technicians, and support personnel. Responsible for team performance, development, and overall productivity.
Work Environment:
- The work environment includes both office and manufacturing floor settings. The manufacturing floor may have higher noise levels and varying temperatures, while the office area is typically climate controlled.
Physical Demands:
- The role involves sitting for extended periods, occasional bending and lifting (up to 50 pounds) and walking within the facility. Some travel between locations and visits to the production floor may be required.
Position Type & Expected Hours of Work:
- Full-time. Typical work hours are Monday to Friday, 8:00 AM to 5:00 PM. Additional hours or overtime may be required to meet project deadlines or address urgent issues.
Travel:
- Expected travel is approximately 20%, primarily for overseeing sister site, client visits, tooling evaluations, and industry conferences. Overnight travel may be required occasionally.
Required Education / Experience:
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.
- Minimum of 3 years experience in an engineering role within the plastics industry.
- Must be able read, write, and understand English.
Preferred Education / Experience:
- Master’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.
- Minimum of 7 years of experience in engineering and tooling roles within the plastics industry, including supervisory experience.
- Experience with Quality Management Systems (ISO 9001, ISO 13485, 21 CFR 820)
- Experience with ERP Systems in an Operations setting
Additional Eligibility Qualifications:
- Professional Engineer (PE) certification or equivalent is a plus.
- Previous experience with complex tooling projects and leading cross-functional teams in a manufacturing environment is highly desirable.
- Certifications in Six Sigma, Lean Manufacturing, or Project Management are a plus.
- Familiarity with advanced manufacturing technologies and automation processes is advantageous.
- Experience with CAD software and injection mould design software is preferred.
Other Duties:
- This job description is an overview of the requirements for the listed job; duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
Pay: $130,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
Work Location: In person
