Helix Medical LLC is the leading global participant with more than 50 years combined experience in contract manufacturing services for the medical, health care, and biotech industries. With operations spanning North America, Central America, Europe, and Asia, we are positioned to meet the needs and expectations of our customers. Come join our amazing and inspiring team!
We are currently hiring for a Senior Process Engineer who:
- Provide sustaining engineering support for all existing processes and production with hands on problem solving techniques
- Can identify and troubleshoot existing process inefficiencies focused on quality and efficiency improvements
- Thrives in a fast –paced, cutting-edge, “lean” systems environment, where priorities can often change on a daily basis
- Focus on daily customer and process related issues to improve quality, on time delivery and process efficiencies.
- Identify, initiate and leads projects to improve productivity and quality through proper investigation and data driven six sigma principals.
- Provide Engineering support for all manufacturing Kaizen events.
- Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
- Close communication with customers, QA, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.
- Participates as a team member on assigned projects using established APQP Project Management tools. Advises Management of any cost related issues for assigned projects.
- Maintain a vigilance to identify new potential technologies for the company.
- Bachelor of Science degree in engineering, preferably plastics or mechanical engineering.
- Minimum 5 years experience working as a process engineer in medical device companies.
- Previous experience or training with project management techniques.
- Technical experience in silicone rubber & (LSR) or plastic processing.
- Experience with Scientific Injection Molding Principles in a related manufacturing environment
- Demonstrated oral and written/technical document creation and presentation skills.
- Familiarity with statistical problem solving and six sigma techniques.
- Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis and recommendation reports.
- Attention to detail and able to work independently and on a team with little supervision
- CAD proficient in 2D dimensioning and tolerance.
- Six Sigma Green or Black Belt certification
- Lean Manufacturing Green or Black belt certification
Helix is a rapidly growing medical device engineering and manufacturing company. We offer a competitive salary plus a full range of benefits including medical, dental & vision insurance, and 401K Plan. Check out our website at www.helixmedical.com.
Candidates meeting these qualifications should send a resume with the Subject: Job Code # SPE 0512
Helix Medical is an Equal Employment Opportunity Employer.
Indeed - 12 months ago