Manufacturing Engineer II

Job DescriptionJob Description

Are you a hands-on problem-solver passionate about improving manufacturing processes? We're seeking a dedicated Manufacturing Engineer II to join our team and drive continuous improvement in a medical device manufacturing environment. If you're a detail-oriented professional with a knack for data-driven solutions and a strong commitment to quality, we want to hear from you.

About the Role

As a Manufacturing Engineer II, you'll be a critical part of our team, owning continuous improvement activities and providing daily support for medical device coating processes. You will use data to measure and enhance Quality, On-Time Delivery, and Cost (QDC) indicators, ensuring our methods and technologies are continually improving and sustainable. This role requires a high level of organization, excellent documentation skills, and the ability to work effectively in a multidisciplinary team.

Key Responsibilities

• Process Improvement: Lead the design, development, and implementation of new manufacturing processes and technologies to increase efficiency and improve product quality.

• Documentation & Validation: Create and maintain detailed documentation, including process routings and work instructions. You'll also lead process validation activities (IQ, OQ, PQ) and support Test Method Validation (TMV).

• Continuous Improvement: Champion a culture of lean manufacturing. You will apply tools like DMAIC, A3, and SPC to solve

• complex technical problems, reduce waste, and enhance productivity.

• Collaboration: Partner with cross-functional teams, including Operations, Quality Assurance, and Supply Chain, to seamlessly integrate new products and processes.

• Problem-Solving: Participate in root cause analysis for non-conforming materials and develop effective corrective and preventive actions (CAPA).

• Mentorship: You may be required to supervise and manage the workload of an Engineering Technician.

Qualifications

• Education: Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field.

• Experience: 3-6 years of hands-on professional experience in manufacturing and process development within the medical device industry (ISO 13485 or FDA regulated).

• Technical Skills:

  • Proficiency in CAD software (SolidWorks, AutoCAD, or similar), including GD&T tolerancing and creating assemblies.

  • Experience with statistical analysis software (Minitab, JMP, or similar).

  • Proven experience with root cause analysis and problem-solving methodologies (e.g., 5 Whys, Fishbone Diagram).

  • Lean Six Sigma Green Belt certification is required, and a Black Belt is a plus.

  • Experience with Fanuc, ABB, or similar industrial/collaborative robots is a plus.

• Personal Skills: You are a highly organized, self-motivated individual with a positive attitude. You have excellent communication skills and a "can-do" mindset.

Why Join Us?

We're a team that believes in Making Quality Personal. We're relentlessly committed to improvement and work together to deliver results. We are dedicated to creating a supportive environment where you can grow and thrive. Our culture is built on teamwork, accountability, and the shared goal of making a difference in the medical device industry.

Ready to apply your skills to a challenging and rewarding role?

Company DescriptionPrecision Coating partners with global MedTech customers to deliver innovative products and services to enhance the surface functionality of their patient critical products. The company operates four facilities: two in Massachusetts, two in Rhode Island, and one in Costa Rica, and serves customers worldwide, offering seamless supply chain support. Additional information about Precision Coating is available at www.precisioncoating.com.

Precision Coating is an Equal Opportunity Employer.Company DescriptionPrecision Coating partners with global MedTech customers to deliver innovative products and services to enhance the surface functionality of their patient critical products. The company operates four facilities: two in Massachusetts, two in Rhode Island, and one in Costa Rica, and serves customers worldwide, offering seamless supply chain support. Additional information about Precision Coating is available at www.precisioncoating.com. \r\n\r\nPrecision Coating is an Equal Opportunity Employer.