Manufacturing Engineer 3

Spectranetics   •  

Colorado Springs, CO

8 - 10 years

Posted 232 days ago

This job is no longer available.

Job Description

In this role, you have the opportunity to

become a process and equipment expert responsible for the support of specific product lines and areas as the primary engineering contact. You will design, optimize and develop improvements to processes and equipment to allow products to be manufactured with efficiency and quality while maintaining compliance to ISO and FDA requirements. You will provide root cause problem solving and disposition of Non-Conformance Requests (NCRs) and Corrective and Preventive Actions (CAPAs).

You are responsible for

  • Owning the capability in lean manufacturing techniques and application of those techniques
  • Use process thinking and lean tools to develop standard work, eliminate waste at the bottlenecks and simultaneously increase productivity, quality, and safety while lowering costs.
  • Develop methodology and best practice criteria for manufacturing engineering. Demonstrate competency evaluating and solving challenging manufacturing situations to meet essential requirements
  • Developing clear and well understood documentation which may include, but is not limited to protocols, deviations, reports, Process FMEAs, drawings, and documentation for acquisition of capital equipment including equipment specification. Also includes detailed, easy to follow SOP and process work instructions for manufacturing. 
  • Initiating, designing, optimizing, and developing systems, equipment and processes in order to meet or exceed department and company objectives. Evaluating, making recommendations and procuring any capital manufacturing equipment required to provide capacity for production of new products.
  • Demonstrating working knowledge of product testing methods for endurance and durability to develop accurate and sound process characterization. Apply technical rigor associated with process validation (IQ, OQ, PQ) for new processes and equipment.
  • Owning quality solutions, including proper disposition and root cause elimination of non-conformance issues.Driving corrective and preventive actions to systemic problems.
  • Develop processes which remove the need for sustaining work – improving safety, quality, output and eliminating scrap. Be mindful of the impact of new processes on our sustaining counterparts. 
  • Develop solutions to safety or ergonomic concerns, which may involve analyzing work methods, developing fixtures or identifying new ways of doing a task.
  • Able to dig deep for root cause, analyze objectively, draw logical conclusions and follow through quickly to deliver solutions. A successful incumbent has a positive mental attitude and can interact with ease within and outside our team to develop and deliver win-win solutions.
  • Developing and designing process monitoring systems to control and verify process requirements.
  • Contributing to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results. Training less experienced personnel on established methods and procedures. Facilitating the transfer of technical knowledge, while demonstrating an understanding of those with a diverse background or experience.
  • Communicating fully with management and others who have a need to know. Being informative without being obtrusive or vexatious. Communicating in a way that is timely, yet prompt; complete, yet concise; candid, yet accurate; and clear, yet responsive.
  • Demonstrate Good Manufacturing Practices (GMP) per regulatory requirements. Working knowledge of AGILE and other quality systems ensuring good documentation practices (GDP) are maintained.

You are a part of

Our ME team and will be highly influential driver, key in supporting our sustaining and production needs for high impact results and helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.

To succeed in this role, you should have the following skills and experience

  • Bachelors of Science degree in an engineering discipline, preferably in Mechanical Engineering but may also be Chemical, Electrical, or Materials Engineering degree; advanced degree is preferred
  • Effective working knowledge and experience with Project Management, Lean, Design for Six Sigma, Design for Manufacturing and Reliability (DRM), DOE, Process Control (SPC), process FMEA, validation/qualification, traceability, and process documentation.
  • Familiarity with the AgileScrum methodology a plus
  • 7+ years’ experience in manufacturing engineering and product/process development, with medical device experiencepreferred.
  • Advanced knowledge of job related tools, processes, testing equipment, and catheter production equipment preferred. Demonstrated history of fast learning for job related tools, processes, equipment required
  • Working knowledge of basic PC programs (WORD, Excel, Power Point, and basic documentation systems). Experience in CAD programs required (SolidWorks preferred).
  • Statistical analysis skill set is required
  • Self-starter, innovative, resourceful, work with minimal direction, and should have excellent skills in problem solving and troubleshooting, oral and written communications, and teaming skills.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.