Manufacturing Engineer *** Direct Hire*** Pay: $100,000.00 – $110,000.00 per year

Excellent Opportunity with thriving Medical Device Company

Responsible for manufacturing and sustaining engineering for a complex electro-mechanical/ optical medical device that is manufactured in a controlled environment. Efforts will focus on improving and/or developing processes, tooling and fixtures for existing products or new products. The ideal candidate will also provide leadership, interface, and support for peers in other departments including Quality, Supply Chain, R&D, and Finance.

Essential Duties and Responsibilities of this Manufacturing Engineer include the following:

• Work with manager and team members to learn products and their associated manufacturing requirements in order to support manufacturing personnel and processes.
• Understand the user needs and requirements for existing products and processes and update them as needed to improve quality, reduce cost to manufacture, and address obsolescence and regulatory changes.
• Lead and participate in cross-functional teams.
• Provide training, direction and manufacturing support for a team of Manufacturing Group Leaders, Assemblers, Engineers, and Technicians.
• Work with the Manager to assure efforts are in full compliance with company Quality policies, ISO and other relevant regulations, company SOPs and manufacturing procedures.
• Prepare quality system documentation such as Engineering Change Notifications, Non-Conforming Material Reports, test protocols and reports, process FMEAs and process maps to support operations and Regulatory submissions.
• Provide leadership and support for manufacturing, sales and quality regarding complaint resolution, product testing, CAPA investigations, and product documentation reviews (specifically including Manufacturing Procedures).
• Set up standard and special purpose laboratory equipment to test and evaluate devices at different stages of assembly.
• Formulate tests, calibrations and procedures to maintain precision accuracy of devices.
• Observe all safety and security procedures; report and manage potentially unsafe conditions, specifically in and around manufacturing areas.
• Communicate regularly to the Engineering Manager and other stakeholders regarding the status of issues and projects.

Core Competencies/Skill and Abilities Required for this Manufacturing Engineer position:

• Strong knowledge associated with electro-mechanical and optical systems.
• Strong knowledge of Adhesive and Solvent bonding assembly of polycarbonates
• Ability to convert manual assembly processes to semi-automated processes.
• Strong knowledge of manufacturing processes associated with single use medical devices.
• Ability to prioritize, plan, and execute work activities efficiently and effectively to meet company, department, and project goals.
• Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

Qualifications:

• Bachelor’s Degree in Electrical, Mechanical or Biomedical Engineering. Five years engineering experience in a medical device manufacturing environment.
• Catheter experience preferred.
• Solid knowledge of QSR, ISO 13485, and the MDD is highly desired.
• Familiarity with LEAN principles preferred. Must have ability to read, understand, and develop SOPs, engineering drawings, and manufacturing procedures.
• Candidate must speak and understand English effectively.
• Excellent communication skills (verbal and written) required.
• Ability to collect, collate, and present data effectively with a solid grasp of statistical techniques a plus.

#Talent