Manufacturing Engineer II: Med Device Process & Launch Lead

Actalent; Maple Grove (MN); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Life insurance

401(k) retirement plan

Job summary

Actalent is seeking a Manufacturing Engineer II to develop robust production processes in a medical device environment focused on breakthrough prostate cancer therapy. You will drive process validation, equipment and fixturing development, and cross-functional collaboration to optimize quality, capability, and cost.

Strong data analysis and leadership in continuous improvement are essential. The role requires hands-on floor support, interpretation of blueprints, and documentation of process

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial, or related engineering discipline.
• 37 years of relevant experience in a manufacturing environment.
• Hands-on experience with medical device manufacturing.
• Experience with process validation, planning, execution and documentation.
• Proficiency with SPC, PFMEA, and control plans.
• Ability to analyze production data with Power BI, Excel VBA, Minitab, or JMP.
• Strong analytical and problem-solving skills with data-driven decisions.
• Excellent communication and cross-functional collaboration.
• Thrives in fast-paced environments with multiple priorities.
• Leadership in continuous improvement and process excellence.

Responsibilities

• Develop, optimize, and sustain manufacturing processes to improve quality and cost.
• Lead design, development and implementation of production equipment, tooling and fixturing.
• Plan and execute process validation activities and maintain validation documentation.
• Create, maintain, and improve control plans, PFMEAs, work instructions, and process docs.
• Analyze production data to identify trends and root causes for improvements.
• Drive continuous improvement to reduce cost, scrap, cycle time and improve OEE.
• Support on-time product launches and smooth transitions to production.
• Collaborate with engineering, operations, quality and other teams.

Skills

Data-driven analysis

Power BI

Excel VBA

Minitab

JMP

OEE

PFMEA

Statistical process control

Process optimization

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Tools

Calibration equipment

Job description

Actalent is seeking a Manufacturing Engineer II to develop robust production processes in a medical device environment focused on breakthrough prostate cancer therapy. You will drive process validation, equipment and fixturing development, and cross-functional collaboration to optimize quality, capability, and cost.

Strong data analysis and leadership in continuous improvement are essential. The role requires hands-on floor support, interpretation of blueprints, and documentation of process