Principal Process Development Engineer
Company: Nextern
Location: Osseo
Posted on: February 10, 2026
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Job Description:
Job Description Job Description As part of a multidisciplinary
process development engineering team the Process Development
Engineer will be responsible for engineering support in the
definition, design, process development, and production transfer of
a wide variety of medical devices. This role includes collaborating
with internal engineers, operations, and key client stakeholders.
DUTIES AND RESPONSIBILITIES: Identify technologies that meet the
manufacturing needs of new product development programs Define
design criteria and author associated documentation including User
Requirements Specifications and Equipment Specifications for highly
automated equipment Oversee vendor design and fabrication of
automated manufacturing equipment Lead the definition and execution
of the Factory Acceptance Testing (FAT), Site Acceptance Testing
(SAT), Installation Qualification (IQ) and process
characterization. Represent the organization as a primary technical
contact for specific projects and initiatives with vendors;
communicates with internal and external customers and suppliers at
various levels Lead efforts for production release of finished
goods and components. This includes BOM’s/routings and other ERP
required information. Develop solutions to complex problems, and/or
makes moderate to significant improvements of processes, systems or
product independently to enhance performance of the area Manage
major/complex projects, involving delegation of work and review of
work products, at times acting as a team leader Make use of
appropriate quality tools, such as DOE, SPC, hypothesis testing,
and capability studies; to measure, monitor, improve and control
the mfg line and select processes Identify process improvement
opportunities and provide technical solutions via analysis and
hands-on interaction with designated processes Utilize project mgmt
skills to drive process development, vendor adherence to program
schedules, and validation projects to completion; on time and on
budget Create written documents, test plans and reports that
demonstrate technical rationale for associated decisions(s) (e.g.
qualifications, risk assessments, and work instructions) Work with
product development engineering to drive back lessons learned as
new products are being developed Provide training and certification
for trainers as required Lead efforts to investigate and develop
new technology related to combination products Requirements
QUALIFICATIONS: Bachelor’s Degree from a four-year college or
university in Industrial Engineering, Mechanical Engineering or
related field. Master’s Degree in Engineering is a plus 10 years of
experience, preferable in the medical device field. Design and
manufacturing knowledge of plastics (extrusions, injection molding
and/or precision parts), stamping, casting and/or sheet metal
fabrication and/or: Experience in the design and development of
interventional catheters. Demonstrated ability to collaborate with,
support and direct mechanical design, review CAD models, part
drawings and BOMs for accuracy and manufacturability. Experience
directing small to medium size projects. Ability to work with
electronic document and project management systems to track work
product, deliverables and progress. Demonstrated ability to provide
complete and accurate work product; material selection, designs,
drawings and other documents that accurately reflect product
requirements and transition smoothly into production. Strong work
ethic and professional commitment The desire to both innovate and
serve internal and external customers by meeting and exceeding
project deliverables and timelines Language Skills: Ability to
write reports, business correspondence, or procedure manuals.
Ability to effectively present information and respond to questions
from groups of managers, clients, customers, and the general public
Computer Skills: Should have knowledge of: SolidWorks, Office Suite
Preferred Qualifications: Working knowledge of data collection,
data analysis, evaluation, and scientific method Benefits Nextern
offers excellent benefits to fuel you in building a fulfilling life
& career: Employer subsidized health insurance for employees
Employer paid dental insurance Employer HSA contribution 401k plan
with a company match 9 paid holidays (including your birthday!) PTO
and Personal days Gym membership subsidy Employee Short Term
Disability, Long Term Disability, and AD&D Life Insurance
Salary Range for This Position: $140,000 - $160,000. Nextern is an
equal opportunity employer. We encourage applications from
candidates of all backgrounds and experiences, and we are committed
to fostering an inclusive and diverse workplace. Qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity,
national origin, disability, or veteran status.
Keywords: Nextern, Woodbury , Principal Process Development Engineer, Engineering , Osseo, Minnesota
