NPI Manufacturing Engineer
NPI Manufacturing Engineer
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1 Vacancy
Job Description
Optikos is seeking a New Product Introduction (NPI) Engineer to join our manufacturing team. In this key role you will work closely with customers and internal teamsincluding optical and mechanical design quality supply chain and manufacturingto prepare novel optical systems for production. This includes both initial builds and full manufacturing ramp-up for internally developed products and customer-supplied designs.
A strong background in medical device manufacturing and a working knowledge of ISO 13485 are essential. Projects span industries such as medical diagnostics defense and virtual reality.
Responsibilities:
- Lead the transfer of optical systems and medical device subassemblies from designinternal or customer-suppliedinto manufacturing readiness.
- Develop and execute NPI project plans including timelines process development risk assessments (FMEA) quality requirements (IQ/OQ/PQ) documentation and resource coordination.
- Serve as the technical liaison between customers engineering and operations.
- Act as a manufacturing advocate during early design phases ensuring DFM/DFA principles and critical specifications are incorporated.
- Collaborate closely with R&D and cross-functional teams to drive manufacturing readiness from prototyping through pilot production.
- Implement and sustain process controls and metrics to ensure repeatable product quality
- Coordinate with Supply Chain for material sourcing and procurement.
- Contribute to cost reduction and continuous improvement initiatives through product process and vendor changes.
- Facilitate customer onboarding for build-to-print programs ensuring accurate documentation alignment on expectations and manufacturing readiness
- Learn from others share your expertise and help build a culture of knowledge exchange.
Qualifications & Skills:
- Bachelors Degree in Engineering or applicable related field (Mechanical Electrical Manufacturing etc.)
- Minimum 5 years of experience in a manufacturing environment building complex mechanical opto-mechanical or electro-mechanical medical devices
- Involvement in transitioning a product from engineering prototype to production on time and within budget which at a minimum includes:
- o Determining efficient assembly processes
- o Assembly documentation (work instructions schematics etc.)
- o Process and product verification
- o Risk Management (PFMEA)
- o ISO 13485 compliance
- Desired experience in some or all of the following areas:
- o Optical alignment metrology and cleanroom assembly processes
- o Six Sigma or Lean Manufacturing Certificate
- o Familiarity with documentation control in regulated environments
- Understanding of GD&T on mechanical and optical drawings
- Experience reading wiring diagrams and electrical schematics
- Experienced user of SolidWorks or similar CAD software and ERP/MRP systems
- Familiar with ISO 9001 and ISO 13485 quality management systems
- Excellent interpersonal skills required to work in a team environment within a diverse group
- Strong written verbal and intrapersonal skills
- Self-starter who possesses organizational critical thinking and problem-solving skills
- Working knowledge of MS Office and related applications (Word Excel PowerPoint)
About Optikos Corporation:
For more than 40 years Optikos has provided innovative applications of optical technology both products and services to commercial government and consumer products organizations worldwide. The Optikos engineering team is the largest independent optical engineering group in the world managing all aspects of instrument design including optics mechanics electronics and software systems in addition to our in-house IQ Lab Services to benchmark and assess the performance of customer lens or camera systems. We develop innovative products in the life sciences aerospace and defense industrial and consumer markets and our experience with a wide variety of applications has enabled our staff to generate creative solutions to some of the most challenging optical problems. Our team continues to improve existing metrology product lines and develop new products that Optikos manufactures and installs around the globe. Our headquarters is centrally located right outside the Boston medical and tech hub in Wakefield Massachusetts.
If you are an enthusiastic team-oriented individual looking for a challenge and the opportunity to continue to develop professionally send us your resume to
This in-office position is located in Wakefield Massachusetts facility. We offer competitive compensation packages along with a challenging and stimulating environment.
Optikos is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion creed sex sexual orientation gender orientation gender identity national origin disability or protected Veteran status.
Employment Type
Full-Time
