Engineer, Manufacturing
Job
Actalent
Minnetonka, MN (In Person)
$86,320 Salary, Full-Time
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Job Description
Actalent is hiring for a Manufacturing Engineer in the Minnetonka, MN area! Job Description This Manufacturing Engineer role focuses on process development within an electrophysiology medical device environment. The position supports the development, validation, and continuous improvement of manufacturing processes and equipment for products used in the treatment of heart disease, with an emphasis on design for manufacturability and robust process performance. Responsibilities Develop and refine manufacturing processes based on product design specifications and performance requirements. Perform detailed analyses to establish and optimize process technologies, considering materials properties, process capabilities, and limitations. Plan and execute comprehensive process validations, including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ). Write, review, and release Installation Qualification (IQ) reports and related validation documentation in accordance with internal procedures and regulatory expectations. Troubleshoot and resolve issues with manufacturing and process equipment to ensure stable and reliable production performance. Provide technical information and guidance on manufacturing techniques, processing methods, and materials to cross-functional teams. Select appropriate techniques, tools, and methodologies to solve process-related problems and make sound design and process recommendations. Assist in developing test methods and inspection processes that align with process capabilities and product requirements. Incorporate design for manufacturability (DFM) principles into process and equipment development to improve efficiency, quality, and scalability. Recognize and address work environment and safety considerations, including adherence to applicable regulations such as OSHA requirements. Collaborate with engineering, quality, and operations teams to support new product introduction and continuous improvement initiatives in the manufacturing environment. Essential Skills Bachelor's degree (B.S.) in engineering. At least 3 years of experience in process development or manufacturing process engineering. Experience developing and validating medical device manufacturing equipment, fixtures, and technologies. Proficiency in executing process validations, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and related activities. Experience performing Installation Qualifications (IQ) for manufacturing equipment. Knowledge of design for manufacturability (DFM) principles and their application to process and equipment design. Ability to troubleshoot and resolve issues with process and manufacturing equipment. Understanding of regulatory and safety considerations in a manufacturing environment, including OSHA-related requirements. Strong technical communication skills for preparing and releasing validation reports and technical documentation. Additional Skills & Qualifications Background in introducer or catheter processing within a medical device manufacturing environment. Experience with Test Method Validation (TMV) and Inspection Method Validation (IMV). Familiarity with Product Performance Qualification (PPQ) and related product validation activities. Experience working in an electrophysiology or broader cardiovascular medical device setting. Demonstrated ability to collaborate effectively with cross-functional engineering, quality, and operations teams. Work Environment The role is based in a manufacturing and process development environment that supports electrophysiology medical device production. Work typically follows a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. The position involves regular interaction with manufacturing equipment, fixtures, and test systems, as well as time spent both on the production floor and in engineering or laboratory areas. The environment emphasizes compliance with safety and regulatory requirements, including adherence to applicable OSHA regulations. Employees are expected to follow site-specific safety practices and wear appropriate attire and personal protective equipment as required for working around medical device manufacturing processes and equipment. Job Type & Location This is a Contract position based out of Minnetonka, MN. Pay and Benefits The pay range for this position is $40.00 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Minnetonka,MN.
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