Senior Engineer, Process Engineering - Individual Contributor

Dexian; Portage (MI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Dexian is seeking a candidate to support process validation activities on the manufacturing line, running samples, collecting data and documenting results. You will work with Quality, Operations and Engineering to ensure processes meet requirements while setting up equipment and troubleshooting issues.

The role requires PPAP, PFMEA, and SOP experience, with a focus on Six Sigma/continuous improvement and strong interpersonal communication across a broad stakeholder network.

Qualifications

• Engineering degree and 4 years of experience in manufacturing validation.
• PPAP, PFMEA, Control Plan, SOPs for product transfers require experience.
• GMP and safety procedures must be followed in all activities.
• Strong statistical methods for process development and data analysis.
• Ability to manage a workstream, drive continuous improvement, and solve complex problems.

Responsibilities

• Support process validation by running samples and documenting results.
• Collaborate with Quality, Operations and Engineering to meet requirements.
• Set up components, fixtures, tooling, and equipment on the assembly line; troubleshoot builds.
• Assist materials team to ensure line is ready to receive components.
• Lead or review in process meetings; participate in PFMEA, PPAP and related qualification activities.

Skills

Process validation

Data analysis

GMP compliance

Six Sigma

Cross-functional collaboration

Problem solving

Education

Engineering degree

Job description

Duration: 12 Months with possible extensions

Job Description:

This role would spend much of the day supporting process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results in validation reports. They would work closely with Quality, Operations, and Engineering teams to ensure processes meet requirements. In addition, they would help set up components, fixtures, tooling, and equipment on the assembly line, troubleshoot issues during builds, and support process improvements as products move into production. Assist and collaborate with materials team to make sure the line is set up to receive components/raw materials. Overall, the position combines hands‑on manufacturing support with technical documentation and cross‑functional collaboration

The role contributes to the delivery of high impact, cost transformative projects. The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations and Divisional partners, therefore strong interpersonal skills and communication skills will be necessary. Position will require PPAP skills, analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings. Participate in PFMEA, Control Plan, SOP, PPAP and other Client internal process qualification generation associated with product transfers.

• Ensure adherence to GMP and safety procedures.
• Equipment Validation Experience.
• Statistical methods for process development.
• Manufacturing/Test Equipment Integration & Troubleshooting
• PPAP experience, ability to manage a workstream and its tasks, Complex problem solving, Six Sigma/continuous improvement
• Engineering degree, 4 years' experience

Medical industry experience STRONGLY preferred

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.