Job Overview:
The Manufacturing Engineer will lead advanced engineering projects to enhance manufacturing processes, optimize production efficiency, and ensure adherence to quality standards. This role requires hands on expertise in process validation, statistical analysis, equipment optimization, and cross-functional collaboration to support business objectives and improve overall manufacturing performance.
Essential Job Functions:
· Lead and execute advanced process and equipment validations (IQ, OQ, PQ, and PV) and develop comprehensive Validation Protocols and Reports.
· Drive process automation initiatives to improve efficiency and reduce variability in production operations.
· Oversee injection molding, extrusion processes, and tooling optimization across multiple product lines.
· Implement and sustain Statistical Process Control (SPC) practices to monitor and enhance process capabilities.
· Perform complex data analyses, including Process Failure Mode Effects Analysis (PFMEA) and statistical evaluations (e.g., ANOVA, capability analysis).
· Develop and monitor Process Control Plans, ensuring compliance with ISO 13485 and FDA regulations.
· Investigate and resolve product complaints and failures using root cause analysis methodologies.
· Mentor cross-functional teams on lean manufacturing principles and spearhead Lean transformation events to improve productivity and reduce waste.
· Collaborate with design teams to ensure the manufacturability of new products and lead seamless design transfers to production.
· Evaluate and implement sampling methodologies for efficient product testing and quality assurance.
· Interface with customers on technical inquiries, process changes, and validation activities.
· Present metrics on Preventive Maintenance, First Pass Yield, and Calibration at management review meetings.
· Develop and maintain systems for monitoring production yields, efficiency, and labor utilization.
· Oversee compliance with safety and quality standards, including OSHA regulations.
· Identify opportunities to minimize production costs and improve throughput while maintaining product integrity.
Qualifications:
The successful candidate will be one who can demonstrate that they have the skill to establish credibility with others.
· Bachelor’s degree in engineering (Mechanical, Chemical, or related field); master’s degree preferred.
· Minimum 5+ years in manufacturing engineering, with a focus on medical devices, pharmaceuticals, or chemical manufacturing.
· 3+ years in plastics injection molding; experience with extrusion processes highly desirable.
· Proven expertise in validation processes and adherence to ISO 13485 and FDA regulations.
· Proficiency with statistical software (e.g., Minitab) and advanced statistical methods.
· Comprehensive understanding of lean manufacturing principles and tools.
· Strong knowledge of production scheduling, run rates, processing times, and equipment changeovers.
· Advanced proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
· Demonstrated success in leading teams and managing complex projects to completion.
· Excellent interpersonal and communication skills for engaging with diverse internal and external stakeholders.
· Analytical problem-solving and decision-making skills.
· Results-driven and self-motivated with a track record of delivering measurable outcomes.
· Strong organizational skills and ability to manage multiple priorities effectively.
· Commitment to maintaining high ethical standards and fostering a collaborative work environment.
· Regularly required to stand, walk, and use hands to operate machinery or computers.
· Occasionally required to lift or move items up to 25 pounds.
· Work environment may include exposure to manufacturing floor conditions
Key Competencies
Why Join Us?
You’ll have the opportunity to make a direct and meaningful impact on manufacturing performance, product quality, and process innovation within a quality driven, compliance focused manufacturing environment where precision and reliability are critical. In this role, your contributions extend beyond operational efficiency, helping ensure that life enhancing and potentially lifesaving products are produced safely, consistently, and at the highest standard, while collaborating with cross functional teams to drive continuous improvement, optimize processes, and deliver outcomes that directly support patient health and well-being.