Sr. Process Development Technician

Job Title:

Sr. Process Development Technician Job Description

The Senior Process Engineering Technician supports the development, validation, and production of medical devices within a regulated manufacturing environment. This role partners closely with NPI, Quality, and R&D Engineering to build, test, troubleshoot, and improve processes and equipment used in the production of implantable and non-implantable medical devices. The technician executes process validations, supports NPI builds, performs equipment qualifications, and assists with root cause investigations to ensure product quality, compliance, and manufacturing efficiency.

This position requires strong technical aptitude, attention to detail, and strict adherence to FDA, ISO, and GMP requirements. This position will support executing development builds, identifying and implementing process improvements, training operators to perform manufacturing procedures, and transferring medical devices from Development to Operations.

• Execute process validations and support NPI builds.
• Perform equipment qualifications and assist with root cause investigations.
• Support executing development builds and identify process improvements.
• Train operators to perform manufacturing procedures.
• Transfer medical devices from Development to Operations.
• Assist in the design of fixturing and procurement of equipment.
• Install and maintain equipment/fixturing.
• Utilize manual and/or automated measurement equipment/tools.
• Draft and optimize manufacturing procedures accurately.
• Identify and implement process improvements including equipment qualifications and documentation.
• Solve problems in a timely manner and understand cause and effect in process development.
• Teach and train others on performing manufacturing procedures.
• Manage and execute development builds and associated build records.
• Work with a positive attitude and act within the corporate guiding principles.

• 2-year degree in a related field or equivalent work experience.
• 5+ years of experience as an individual contributor with a strong focus in Product or Process Development.
• Demonstrated ability to successfully launch devices from Development to Operations.
• Strong background in assembly and experience working in a cleanroom environment.
• Knowledge of medical component or device manufacturing.
• Solid technical ability with demonstrated attention to detail.
• Focus on quality and excellent written and verbal communication skills.
• Ability to work well with teams and handle confidential information.
• Capacity to work in a fast-paced, constantly changing environment.
• Ability to handle multiple projects in an organized, timely manner.
• Problem-solving skills, ability to work under pressure, and manage stress effectively.

• Proficiency in Validation, Solid Works, and equipment troubleshooting.
• Highly skilled in prototyping and understanding manufacturing processes.
• Ability to work with limited supervision.

The company offers a great working environment with a clean, state-of-the-art facility and break room. The culture is vibrant with many events, lunches, and BBQs that bring people together. Work hours are 1st Shift, Monday to Thursday, from 5 am to 3:30 pm, with a 30-minute paid break, a 30-minute unpaid lunch, and a 15-minute paid break.

This is a Contract position based out of Minneapolis, MN.

The pay range for this position is $35.00 - $45.00/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)