Principal Manufacturing Engineer

Principal Manufacturing Engineer 3.3 3.3 out of 5 stars 64 Technology Park Road, Sturbridge, MA 01566 $115,000

• $125,000 a year
• Permanent, Full-time Optim LLC 3 reviews $115,000
• $125,000 a year

•

Permanent, Full-time Job Summary:

Optim LLC is seeking a dynamic and highly skilled senior-level leader to drive new product industrialization, optimize production processes, and ensure high-quality, scalable manufacturing operations.

Core Responsibilities:

Full manufacturing process participation, including: creating manufacturing instructions, training operators, process optimization, cost reduction, and design transfer to manufacturing.

Primary Duties:

Create and maintain product and system documentation to meet internal and external customer needs. Identify and evaluate manufacturing methodologies, assess process capabilities, and prioritize process improvement opportunities to improve quality and reliability and to reduce manufacturing costs. Produce clear and accurate technical documentation to promote quality and efficiency in day-to-day work. Provide technical support to establish new components, meet critical quality parameters and stay on time with development and production schedules. Author equipment installation and qualification protocols and reports.

Additional Job Requirements:

Leverage external partners as necessary to achieve project objectives. Train and provide direction to manufacturing personnel when required. Work closely with and establish critical suppliers. Work with Quality on in-process and final inspection processes and equipment. Support and follow all company Quality Management Systems policies and procedures.

Supervisory Responsibilities:

N/A Education and Experience:

BS in Mechanical, Electrical, Biomedical Engineering or similar. Direct experience in product or process development. Plus for reusable medical device development experience. Demonstrated commitment to quality through good documentation practices. 2-5 years of work experience in medical devices or a related field preferred. Experience with electromechanical systems and working in a GMP environment preferred. Familiarity with PLMs and ERP systems preferred. Proficiency in problem analysis and problem resolution (8D, PFMEA, 5 Why's) preferred. Experience with

ISO 13485, CFR

820, and MDR preferred. Proficiency in creating and maintaining Device Master Records, Technical files, and Design History files preferred. Why join Optim LLC? Optim LLC develops, manufactures, and supports state-of-the-art endoscopy products and accessories that help medical professionals, law enforcement officers, and industrial users work more effectively and efficiently. We take pride in our work and accomplishments, which all begins with our employees. With an ever-growing market, we are looking to add and advance our workforce with meaningful career and growth opportunities. Our culture is centered around innovation, partnership, and empowerment.

Pay:

$115,000.00

• $125,000.

00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance Application Question(s): Will you now or in the future require employment visa sponsorship (e.g., H-1B, O-1, etc.)? How long would your commute be?

Work Location:

In person