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Openings >> Development Engineer
Development Engineer
Summary
Title:Development Engineer
ID:1266
Department:Product Development
Location:Sandpoint, ID
Description
Biomedical Innovations, a Nissha company, is the premier medical device contract manufacturer. We provide product development, assembly, and packaging services to the medical device industry.

We are currently seeking a full time Development Engineer to support design, manufacturing development, and the transfer of new products to Production. This position will assist in the selection and specification of new assembly or automated equipment and be responsible for the design, testing, and integration of manual and semi-automated processes and equipment needed to support new products. Coordinates and performs process validation per ISO 13485 and FDA requirements. Knows and applies fundamental concepts, practices, and procedures of particular field of specialization.

Essential Responsibilities Include:
  • Create production specifications (Drawings, specifications, manufacturing assembly instructions, work instructions, etc.) based on customer requirements
  • Design manufacturing equipment, tooling, and fixtures.
  • Participate in fabrication of prototype, first article samples, and test equipment.
  • Develop manufacturing processes to meet customer and Biomedical Innovations requirements, in accordance with ISO 13485 and FDA regulations.
  • Validate manufacturing processes. Facilitates or performs process characterization and process validation on components/products according to Biomedical Innovations procedures and / or customer requirements.
  • Facilitate initial tooling and fixture trials. Troubleshoot tooling performance, process performance, design and material related issues during manufacturing start up.
  • Train Production personnel in product assembly and inspection.
  • Generate engineering change orders, protocols, and reports. Create work instructions (WI’s) and standard operating procedures (SOP’s) for products, and machines for new customer processes
  • Participate in project teams and conference calls while representing Biomedical Innovations to the customer.
  • Develop appropriate vender contacts, approve prototype raw materials and assists in vender certifications.
  • Assist manufacturing engineering with current product process improvements as required. Participate in design reviews to modifications to processes.
  • Coordinate and perform design reviews with manufacturing engineering of new customer processes through the RTM process.
  • Troubleshoot electrical, mechanical and software for machine and system use as required.
  • Work with the Automation Engineers as needed to evolve products/processes into full automation assembly.
  • Regular attendance
  • Abide by all safety and security rules set by the company and regulatory agencies
Minimum Qualifications:
  • BS in Manufacturing or Mechanical Engineering. Work experience in Process or Manufacturing Engineering may substitute for the education requirement on a year-for-year basis.
  • Minimum one year experience in Manufacturing or Process engineering required. Five years’ experience preferred.
  • Mechanical and machine shop ability desired with strong mathematical skills.
  • Strong computer skills and working knowledge of 3D CAD (SolidWorks preferred).
  • Full understanding of Lean Manufacturing processes required.
  • Strong communication and interpersonal skills with the ability to explain complex information to all levels.
Great benefits offered including medical, dental, 401K, education assistance, and more!

Biomedical Innovations is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.

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Advancement Opportunities

We believe in promoting and growing talent from within! Employees are offered opportunities to apply for open positions.

Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
  • Service Awards

Diversity EEO Statement

Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

Culture

For over 60 years, Graphic Controls has been a Company that values it's employees and their hard work. Employees are offered great benefits and opportunities which make coming to work everyday something to look forward to. Employee satisfaction is proven by the simple fact that our average length of service is over 15 years.