Senior Manufacturing Engineering Technician

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.
• Absorb 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.

Required Skills, Knowledge, Experience & Qualifications

• 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.

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.