Are you looking for an opportunity to apply your technical skills to assist in the development of complex, state-of-the-art design and manufacturing processes for medical devices? Do you enjoy developing prototypes, equipment and processes to transition exciting new products to the production floor? Do you have a drive to contribute, learn, and be an integral member of a high-performance manufacturing team?
If your answer is yes, then we may be looking for you!
Spectranetics, now a part of Philips Image Guided Therapy Devices, has an opening for a Senior Manufacturing Engineer.
What You Will Do: As part of the Spectranetics team, the Senior Engineering position will be responsible for developing processes for medical device products meeting ASTM standards. You will also own the transition of these products and processes in the transition from engineering to production. The successful candidate will have experience in the medical device manufacturing and other product types that meet industry, customer, and regulatory standards. This individual will be part of a world class team unsurpassed in creating real solutions for our customers. You will also support all other applicable Advanced Manufacturing Engineer team needs.
What You Will Learn: We attract and hire the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from our Engineers, Clinicians, Sales Leaders, and other industry professionals about all facets of state of the art medical device development. You will be exposed to clinical leaders to understand the needs behind the products you help to develop.
What You Will Become: A capable technical teammate with an understanding of relevant job related tools, processes, testing equipment and experience developing new medical devices to meet those needs. A highly influential driver who will be key in supporting our sustaining and production needs for high impact results helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
Becoming an integral member of cross-functional Product Development core team(s); confirming designs for manufacturing and working with Product Development Engineers to develop robust designs and processes for manufacturing to deliver products safely to customers.
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.
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.
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 solutions to safety or ergonomic concerns, which may involve analyzing work methods, developing fixtures or identifying new ways of doing a task.
Owning the capability in lean manufacturing techniques and application of those techniques
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.
May supervise or direct the work of other engineers or technicians to accomplish team goals
Job Related Skills:
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
Individual should be a 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.
5 to 7 years' experience in product design and processing methods in manufacturing and product/process development.
Experience in Medical Device Industry is a must.
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
Preferred candidate will have 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 Agile Scrum methodology a plus
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status or status as an individual with a disability.