Process Development Engineer-Molding

Very highly visible career opportunity is available for a Process Development Engineer with knowledge of Molding in the medical device/contract medical device manufacturing industry. We are seeking a highly organized, motivated and well-rounded individual who will be responsible for process development, process validation, process documentation & procedures, operator training and production support. Other duties will include participation in exploratory customer meetings and sales calls, quoting, material review and assessment, mold design reviews and assisting in the development of fixtures and methods for effectively loading and unloading inserts for overmolding cannulae/needles/wires, etc.

This is an exciting opportunity for an aggressive and experienced Molding Engineering professional to work for a world-class leader in our industry. Other responsibilities include:

Responsibilities

• Provide timely communication and project management skills to deliver smooth transition for each project into production.
• Support customer requests for quote, and to help pull new projects won through the development process into production.
• Ensure consistent quality components are produced that meet customer expectations.
• Ensure proper equipment operation and preventative maintenance schedules are performed.
• Develop and maintain strategic relationships with outside tooling providers to ensure short lead times and quality workmanship for tool design and fabrication as needed.
• Participate in the planning and evaluation of new business opportunities including assessments of technical fit and capacity constraints.
• Track and monitor key performance indicators and take corrective action when necessary.
• Compliance to Good Manufacturing Practices (GMP) and all documented procedures in the Tegra Medical Quality Management System.
• Perform other related duties and responsibilities as required.

Qualifications

B.S. in Plastics or Mechanical Engineering and at least 5-10 years of mold design experience working with medical grade polymers is required. Must have experience in insert molding and working with production operators in regulated industries such as Medical Devices, including ISO 9000 requirements. Should also have understanding of statistical process control, DOE and good familiarity with process validation procedures.

Must also have excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall quality of delivery and a demonstrated ability to build effective business relationships across all levels of business. Should possess outstanding technical, problem solving and analytical abilities as well as be able to manage projects of complex, multi-tool programs with process capabilities studies and be flexible, possess strong leadership and interpersonal communication skills. Must have strong decision making capabilities, the capacity to handle confidential information and be able to travel as required.

We offer excellent compensation & benefits and a terrific work environment.

Please email your resume and salary expectations to:

Human Resources Department

Tegra Medical

8 Ledgewood Blvd., Dartmouth, MA 02747

Fax: 508.590.8373/email: hr@tegramedical.com

An Equal Opportunity Employer

M/F/D/V