Medical device company focused on restoring peripheral nerve function and improving quality of life through innovative solutions.

Axogen, a leading medical device company, is seeking an Engineer I, Quality Systems (Computer System Validation) to join their innovative team. This role presents an exciting opportunity to contribute to the company's mission of restoring health and improving quality of life through peripheral nerve function restoration.

The position offers a comprehensive benefits package effective from day one, including health, dental, and vision insurance, 401(k) matching, and various flexible spending accounts. The company promotes a friendly, open culture that values unique perspectives and maintains a strong commitment to professional growth.

As an Engineer I, Quality Systems, you'll be responsible for supporting IT and business system owners in computer system validations and data integrity assessments. This role is perfect for someone with a Bachelor's degree in Biomedical, Mechanical Engineering, or related field, who is starting their career in the medical device industry.

Key responsibilities include reviewing validation deliverables, collaborating on risk assessments, contributing to validation planning, and supporting audit processes. The role requires excellent communication skills, strong organizational abilities, and the capability to manage multiple priorities effectively.

The position offers a competitive salary range of $61,194 - $76,491 USD and follows a hybrid work schedule with 3 days in office and 2 days remote. This is an excellent opportunity for someone looking to build a career in quality systems engineering while making a meaningful impact on patient care.

The company's commitment to innovation, patient care, and professional development makes this an ideal role for candidates seeking to grow their careers in the medical device industry. You'll be part of a team that directly contributes to improving patient outcomes while working in a supportive, growth-oriented environment.

Entry-level Quality Systems Engineer position focusing on computer system validation and data integrity in the medical device industry.

Engineer I, Quality Systems (Computer System Validation)

Medical company focused on peripheral nerve function restoration and improving quality of life through innovative medical solutions.

Axogen, a leading healthcare company specializing in peripheral nerve function restoration, is seeking an Engineer I - Manufacturing/Processing for their Vandalia, OH facility. This role combines engineering expertise with medical device manufacturing, offering an opportunity to directly impact patient care through innovative medical solutions.

The position requires a Bachelor's degree in Engineering or related field, with 1-3 years of experience in a regulated industry. The ideal candidate will have experience in tissue engineering and regenerative medicine products, though this is not mandatory. This role offers a comprehensive benefits package including health insurance, 401(k) matching, and equity opportunities through their Employee Stock Purchase Plan.

As an Engineer I, you'll be responsible for supporting daily production operations, leading continuous improvement projects, and collaborating with R&D and Quality Management teams. The role offers a hybrid work arrangement for some positions, demonstrating Axogen's commitment to work-life balance.

The company culture emphasizes professional growth, innovation, and making a meaningful impact on patients' lives. With a salary range of $61,194 to $76,491 USD and an extensive benefits package effective from day one, this position presents an excellent opportunity for an engineer looking to grow in the medical device industry while contributing to life-changing medical solutions.

Working at Axogen means joining a team dedicated to advancing medical science and improving patient outcomes, with opportunities for professional development and career advancement in a collaborative, innovative environment.

Entry-level Manufacturing/Processing Engineer position at Axogen, focusing on medical device production and process improvement with competitive benefits and hybrid work options.

Engineer I - Manufacturing/Processing

Axogen is a healthcare company focused on restoring peripheral nerve function and improving quality of life through innovative medical solutions.

Axogen, a leading healthcare company focused on peripheral nerve function restoration, is seeking a Senior Quality Engineer to join their team. This role combines engineering expertise with quality assurance in a medical device manufacturing environment. The position offers a comprehensive benefits package and the opportunity to make a meaningful impact on patients' lives.

The ideal candidate will bring 5+ years of quality engineering experience in medical device or pharmaceutical manufacturing, along with a strong foundation in engineering principles and quality management systems. You'll lead quality planning activities, participate in product development, and ensure compliance with various regulatory requirements including FDA and ISO standards.

Working at Axogen means joining a company with a clear mission to improve healthcare outcomes. The company offers a collaborative culture that values unique perspectives and professional growth. With a hybrid work model, competitive salary range of $81,737 - $102,171, and extensive benefits including health insurance, 401(k) matching, and stock purchase options, Axogen provides an excellent environment for career development.

Key responsibilities include leading quality planning initiatives, conducting risk management activities, and ensuring regulatory compliance. You'll work cross-functionally with various departments, from Product Development to Operations, making this role ideal for someone who enjoys diverse challenges and strategic thinking in quality engineering.

The position requires occasional travel (up to 30%) and offers the opportunity to directly impact patient care through quality assurance in medical device manufacturing. If you're passionate about healthcare innovation and quality engineering, this role offers a chance to contribute to life-changing medical solutions while advancing your career.

Senior Quality Engineer position at Axogen, leading quality assurance initiatives in medical device manufacturing with focus on regulatory compliance and product development.

Sr. Engineer, Quality

Axogen is committed to building and maintaining a strong company culture that fosters professional growth and impacts patients' lives.

Axogen is seeking a Sr. Engineer, Quality Control to join their team. This role provides test method and qualification support, implements new processes, and drives continuous improvements in the Quality Control laboratory. The ideal candidate will have a Bachelor's degree in chemistry/biology or a related field, with 5+ years of experience in Quality Control, R&D Laboratory, or Quality Engineering, preferably in Biologics or Pharmaceuticals. Key responsibilities include driving OOS investigations, developing protocols for method improvements, managing commercial stability studies, and leading BLA support activities. The role requires expertise in quality control instrumentation, data analysis, and quality system regulations. Axogen offers a comprehensive benefits package, including health insurance, 401(k) matching, paid time off, and an employee stock purchase plan. The company culture values unique perspectives and is dedicated to impacting patients' lives positively. This position is based in Vandalia, OH, with a salary range of $79,356 - $99,195 USD. Axogen follows a hybrid work schedule for some positions, with 3 days in office and 2 days remote, though this may not apply to all locations.

Sr. Engineer, Quality Control at Axogen: Lead QC improvements in biologics, manage stability studies, and drive BLA support.

Axogen Engineering Jobs

Medical device company focused on restoring peripheral nerve function and improving quality of life through innovative solutions.