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