Ardent Staffing Solutions
Our Passion Is People
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.
- 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.
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