What are the responsibilities and job description for the Manufacturing Engineer (Medical Manufacturing Industry) position at Complete Staffing Solutions?
Manufacturing Engineer
Medical Manufacturing Industry
Compensation
Location: Torrington, CT
Compensation range: $100,000-120,000
We are seeking a hands-on, results-driven Manufacturing Engineer to support the seamless transition of new products from development into full-scale production within our regulated medical injection molding and assembly facility. This role is critical to driving process excellence, ensuring compliance, and enabling scalable, cost-effective manufacturing. The ideal candidate will combine strong technical expertise with practical project execution skills and a continuous improvement mindset.
Key Responsibilities
Medical Manufacturing Industry
Compensation
Location: Torrington, CT
Compensation range: $100,000-120,000
We are seeking a hands-on, results-driven Manufacturing Engineer to support the seamless transition of new products from development into full-scale production within our regulated medical injection molding and assembly facility. This role is critical to driving process excellence, ensuring compliance, and enabling scalable, cost-effective manufacturing. The ideal candidate will combine strong technical expertise with practical project execution skills and a continuous improvement mindset.
Key Responsibilities
- Project Leadership
- Lead manufacturing engineering activities for new product introductions (NPI), from concept through validation and production ramp-up.
- Manage project timelines, deliverables, and risk mitigation strategies to ensure on-time, in-spec, and in-budget launches.
- Process Design & Optimization
- Develop, optimize, and scale injection molding and secondary assembly processes to ensure consistent quality, high efficiency, and cost-effectiveness.
- Apply lean principles, data analytics, and root cause methodologies (5-Whys, Fishbone, etc.) to eliminate waste and reduce variability.
- Tooling & Equipment Management
- Oversee the specification, procurement, and validation of molds, jigs, fixtures, and custom equipment.
- Collaborate with toolroom personnel and external vendors to manage tooling performance, modifications, and preventative maintenance.
- Documentation & Training
- Create and maintain robust documentation including process flow diagrams, work instructions, SOPs, and validation protocols.
- Lead operator training and knowledge transfer for new or revised manufacturing processes.
- Compliance & Validation
- Develop and execute validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, and GMP requirements.
- Ensure all processes meet regulatory standards and are audit-ready at all times.
- Cross-Functional Collaboration
- Partner with Program Management, Quality, Operations, and Supply Chain to ensure design for manufacturability (DFM), smooth tech transfers, and issue resolution.
- Facilitate manufacturing readiness reviews and support customer communications as needed.
- Continuous Improvement
- Drive Kaizen initiatives, lead root cause investigations, and implement sustainable corrective and preventive actions (CAPA).
- Identify and execute cost reduction and efficiency improvement projects without compromising quality or compliance.
- Education:
- Bachelor’s degree in Manufacturing, Mechanical, Industrial Engineering, or related discipline.
- Experience:
- 2–5 years of experience in a manufacturing engineering or process development role, preferably in medical device, injection molding, or other regulated industries.
- Technical Proficiency:
- Strong understanding of injection molding processes, mold qualification, and downstream assembly operations (e.g., ultrasonic welding, pad printing, packaging).
- Hands-on experience with tooling design, procurement, and maintenance.
- Proficient in process validation methodologies (IQ/OQ/PQ).
- Skilled in statistical analysis tools (e.g., Minitab, Gainseeker) and process monitoring.
- CAD experience required; simulation tools a plus.
- In-depth knowledge of ISO 13485, ISO 9001, FDA, and GMP standards.
- Soft Skills:
- Strong project management and organizational abilities.
- Excellent problem-solving and analytical thinking.
- Effective communicator across functions and levels.
- Customer-facing experience is a plus.
- High sense of urgency, ownership, and adaptability.
- Work is performed in both office and production/cleanroom environments.
- Must be able to stand, walk, and interact with manufacturing equipment daily.
- Ability to lift up to 25 lbs.
- Must adhere to cleanroom and safety protocols.
Salary : $115,000
