Senior Manufacturing Engineer
Company: Ortho-Clinical Diagnostics
Posted on: June 7, 2021
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving
lives with diagnostics. To do this we hire people who share this
dream and are ready for new adventures. As a valued team member,
you will carve your own career path and be part of building this
company stronger and better than ever before. There is no limit to
the experiences, opportunities and new directions you will have
access to here at Ortho Clinical Diagnostics. More importantly, you
will be driving the surge of a whole new direction in important
medicine. That's something we can all take pride in as we take this
Ortho is known in the industry as a leader in customer service
and support. Deeply understanding and exceeding the needs of our
clinical lab, hospital and blood bank customers is what we do. It's
who we are. If you join Ortho, no matter what your role, you will
be expected to keep that Customer Excellence focus in your
As the company continues to grow we are seeking a Senior
Manufacturing Engineer. The Senior Manufacturing Engineer will be
deployed to assist New Product Introduction (NPI) programs to
ensure flawless execution of Design Transfer activities and the
successful operational implementation of manufacturing processes at
both internal and external Electro Mechanical manufacturing partner
sites. The individual will partner with R&D teams through the
design phase to ensure operational and supply chain requirements
are understood by the project team in addition to the early
identification of product and/or manufacturing requirements that
need development of new manufacturing capabilities and/or
competencies. The role will involve collaboration with both
external component suppliers, external manufacturing sites and
internal manufacturing sites as design specifications received from
the R&D design team are translated to supplier and
This position is located in Rochester, NY.
For NPI and LCM Programs, work closely with R&D, Quality,
and Ortho Care, leading team activities to resolve manufacturing
issues identified through Specification Variance (SV) and Supplier
Change Request (SCR) processes.
For NPI and LCM Programs, the Senior Manufacturing Engineer will
be responsible for part and assembly qualification, utilizing
Production Part Approval Process (PPAP) data provided by the
external manufacturing partner, and collaborating with Ortho
R&D, Quality, and Ortho Care to provide Ortho approval.
For NPI Programs, ensure flawless execution of Design Transfer
activities and the successful operational implementation of
manufacturing processes at both internal and external Electro
Mechanical manufacturing partner site.
For LCM and new programs, the individual will be responsible to
review drawing and make recommendations for cost reduction
opportunities. The engineer will also be responsible to drive
drawing changes in the PLM system.
Provide Red-lines to drawing changes until supplier can
adequately provide red-lines.
- Provide technical resources to manufacturing related fixtures
located at external suppliers.
BA/BS with 6-10 years experience or MS with 5-7 years experience
in Mechanical Engineering or equivalent technical degree.
The products primarily supported by this position will require
an electromechanical device process development engineering skill
A broad-based knowledge of assembly and component manufacturing
processes within the Diagnostics and/or Medical Device Industry is
Demonstrated ability to lead, under minimal oversight, elements
of complex technical projects confidently is strongly
Experience in an FDA regulated and/or GMP environment is
This position requires someone with very strong communication
(both written and verbal) as well as influencing skills as
interaction with multiple functions and various suppliers is
Experience in process improvement efforts using Process
Excellence, Six Sigma and Lean Tools is preferred.
Proficiency with Microsoft Office is required.
Knowledge of Product Data Management tools (PDM) is
Proficient in reading and interpreting GD&T, tolerance
Coach less experienced engineers in process/design changes. Lead
by example when completing daily work. Work within the team dynamic
to promote Win-Win solutions to problems. Ownership and
accountability to project results is clearly demonstrated.
- Required travel 5% domestic or international.
Keywords: Ortho-Clinical Diagnostics, Rochester , Senior Manufacturing Engineer, Other , Rochester, New York
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