JO-3448
| Title: | | Principal Sterilization Engineer | | Degree/Education: | | B.S. Engineering/Technical Field | | Experience: | | 8 Plus Years | | Salary/Bonus: | | Competitive with Bonus up to 20% | | Location: | | Midwest | | Packaging Specialty: | | Medical Devices | | Travel: | | 10% | | Relocation Provided: | | Yes | | Reason Job is Available: | | Newly created |
DESCRIPTION:
The Principal Sterilization Engineer will independently
conduct development work as part of a major research and/or development project. He or she will receive minimal technical
direction/review on broad scope or complex projects. This individual will be viewed as an expert relative to in-house
sterilization technologies and additionally the scope of the position includes: - Functioning
as the technical NPD expert in sterilization and microbiological control issues, evaluating technical and regulatory requirements
against business needs.
- Participating on company teams representing
sterilization requirements for new product development (NPD).
- Leading divisional
NPD sterilization teams and advises management on technical matters.
- Driving global
solutions, innovation, and technology solutions related to sterile product.
- Assuring
the sterility of medical devices and drug coatings.
- Driving complex or
novel assignment requiring the development of new or improved techniques and procedures. Work is expected to result in the
development of new or refined technologies, products, materials, processes, equipment, and/or scientific method to broaden
the company’s Intellectual Property in key strategic areas.
- Successfully completing
engineering work in one or more of the following: technology development, product design and development, test of materials,
preparation of specifications, process study, research investigation (animal and clinical studies), sterilization and report
preparation.
- Providing guidance to product and technology teams.
- Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
- Coordinating,
managing, and documenting project goals and progress and recommends appropriate revisions.
- Interfacing with Physicians/Cath Lab personnel to identify needs and to obtain feedback on concepts and performance
of new devices and to translate customer needs into product concepts.
- Developing
and coaching others on engineering documentation.
- Training and/or providing
work direction to technicians and less experienced engineers.
- Leading engineering
teams to the successful completion of project goals.
- Demonstrating
PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables.
This position
reports to the Director of Packaging.
REQUIREMENTS:
Qualifications will include
a minimum education/years experience: B.S. in Engineering/Technical Field; with 8 Plus years experience (7 Plus years with
MS, 4 Plus years with Ph.D.). Minimum of 8 years of related medical device sterilization experience is required.
Experience with Ethylene Oxide (EtO) sterilization is required. Superior Project Management experience and strong leadership
skills are critical. Strong analytical and communication skills are required. Experience with Radiation (Gamma) sterilization
preferred. Experience with D.O.E. preferred. Looking for someone with engineering background if possible (vs. microbiology).
Not looking for Quality sterilization. Regulatory experience required. More operational end, troubleshooting.
Might rebuild equipment. This is a new position – they don’t have another one like it in their facility
at this time. The company is looking for an expert.
If already
working with a Quality Search Representative, they will appreciate
you contacting them direct at:
The
position above is very “Active”. If you are interested, and
a good fit, you must let us know. If you are not, we thank you for passing along to a colleague who could benefit!
Note: We must have a current Resume
to represent you and all inquiries will be handled professionally. Please go here for instructions on submitting a copy of your resume to us.
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