Pharma Validation Engineer Jobs in Minnesota (NOW HIRING)

We are seeking a Sr Manufacturing Engineering Technician to provide hands-on technical support to the manufacturing engineering team. This role focuses on equipment setup and maintenance, fixture and tooling development, routine testing, data collection, and technical documentation. Working under the guidance of senior staff, the individual will help ensure efficient day-to-day operations while supporting manufacturing processes, process development, and continuous improvement efforts.

At Anteris® Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Key Responsibilities

• Perform assigned tasks in compliance with company procedures, safety requirements, and the Quality Management System.
• Manage and execute preventive management (PM) activities for manufacturing equipment and support routine PM efforts as needed.
• Assist engineers with equipment setup, qualification activities (IQ, OQ, PQ), and validation of test and inspection methods.
• Support the design, development, and fabrication, and prototyping of manufacturing aids, tooling, and fixtures.
• Assist with testing activities, sample preparation, data collection, and documentation of results.
• Develop, maintain, and organize manufacturing training materials, and support the onboarding and training of new hires (e.g., production assemblers or operators).
• Operate laboratory and test equipment as trained; perform basic troubleshooting and escalate equipment issues, nonconformances, or deviations in accordance with quality procedures.
• Identify procedural gaps and recommend revisions, corrections, or process improvements to enhance clarity, compliance, and efficiency.
• Follow GDP and accurately record results and maintain records using established formats and systems.
• Perform basic cleanroom support activities (e.g., material handling, environmental monitoring) as required.
• Follow gowning procedures and maintain compliance with controlled environment standards (e.g., ISO Class 7/8 cleanroom standards).
• Participate in training, continuous improvement initiatives, and cross-functional activities as assigned.
• Carry out other duties as assigned by the manager or delegate.

Skills, Knowledge, Experience & Qualifications

Required:

• Associate's degree in a technical field, trade school certification, or equivalent hands-on experience with 5-10 years of experience in a regulated manufacturing or engineering environment (medical device, pharma, aerospace, or similar).
• Strong knowledge of equipment operating principles, and measurement tools (calipers, micrometers, gauges).
• Comfort working in controlled environments (e.g., cleanrooms) when required.
• Proficiency with computer skills for data entry and, documentation (Excel, Word, Outlook, and PowerPoint)
• Strong attention to detail, willingness to learn, and ability to follow procedures.
• Effective verbal and written communication skills.
• Experience with equipment calibration, preventive maintenance, or testing processes.

Preferred:

• Proficiency with CADs (SolidWorks, Corel Draw, etc) and engineering drawings.
• Experience working with 3D printers, laser cutting,
• Prior experience in a regulated environment (ISO 13485, FDA, or similar).
• Experience in tissue heart valve manufacturing, including tissue processing, solution preparation and sewing.

Compensation:
Target base salary range: $36 - $44 /hr. Final compensation will be based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Inclusive Team Environment - collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings:

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program