Sr Process Engineer - Exempt, Tennessee

Top 3 technical skills that are required for the role:

Process Development, including characterization, process and equipment qualification, validation activities

Problem solving – demonstrated ability to resolve production issues

Manufacturing and quality experience: Able to partner with operations and quality to develop manufacturing methods and work instructions

Education Required: Bachelor’s degree in engineering, science or related discipline

Years’ Experience Required: 4 years

Will the contractor be working 40 hours a week? Yes

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite

What is your timeline for scheduling interviews? ASAP

What product line will this person support? Neuromodulation and Pelvic Health Programmers

At our company, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Process Engineer, you will be responsible for developing and supporting production processes that may include software loading, testing, assembly, kitting, and packaging operations. The position will also coordinate the introduction of new products and processes to the production floor ensuring the timely introduction of capable and proven processes.

The employee will be part of the Operations New Product Introduction team based in Minnesota and co-located with the Manufacturing Team in Memphis to define, develop and test new products for the Neuromodulation business.

Responsibilities

Development of device processing, assembly and packaging methods for assigned product lines.

Proactively execute and support validation/qualifications activities (e.g. IQ, OQ, PQ, Characterization)

Partner with Quality Engineering to ensure proper process compliance, including quality documentation (e.g. work instruction, quality system reports, etc.)

Partner with Quality during risk management activities. May lead and/or actively participate in risk management documents review, e.g. Design and Process Failure Mode and Effects Analysis

Resolve technical production problems on assigned product lines in finishing and assembly and packaging operations working with shop employees and quality personnel.

Collaborate cross-functionally to develop new line layout and infrastructure to support assigned products. May make recommendations to management on plant layout.

May recommend and implement manufacturing equipment acquisitions. Work with equipment suppliers on equipment specifications, quoting of specified equipment and delivery schedules.

Initiate and direct improvements in current manufacturing methods and processes to improve quality performance, process efficiency, and to reduce manufacturing costs

May lead in the training of direct and indirect team members

Ensure processes and procedures are in compliance with regulations (21 CFR 820) and company Quality Systems.

Provide periodic updates of assigned projects to senior management, maintain project documentation, project plans, action item registers and actively manage risks related to cost, quality and schedule.

Performs other duties as assigned.

Must Have (Minimum Requirements)

Bachelor’s degree in engineering, science or related discipline with minimum 4 years relevant experience.

Experience in Process Development, including characterization, process and equipment qualification, and validation activities

Experience in quality documentation activities within highly regulated environments

Excellent Communication skills, both written and verbal

Ability to collaborate cross-functionally

Nice to Have

Medical device industry experience.

Experience in Design Transfer

Experience supporting various equipment, including testing, firmware or software loading, and related processes

Experience working with Manufacturing Execution Systems

DRM and/or Lean Six Sigma Certification