Engineer I, Quality

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Flexible working hours
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Engineer I, Quality

The Engineer I, Quality is responsible for providing quality and compliance related support for the development, manufacture, and distribution of healthcare products (biologic, human tissue, and medical device products) in accordance with applicable regulations and standards. This position reports to the Manager, Quality Engineering.

Requirements of the Engineer I, Quality

• Bachelor's degree in biomedical engineering, mechanical engineering or similar field required.
• 0-2 years' experience in manufacturing, product development, or quality engineering medical device, pharmaceutical, or other highly regulated industry.
• Well-organized, with the ability to efficiently manage multiple competing priorities.
• Ability to work independently and in a collaborative team environment.
• Excellent oral and written skills.
• Excellent intrapersonal and team-building skills.

Responsibilities of the Engineer I, Quality

The specific duties of the Engineer I, Quality include but are not limited to:

• Assist in quality planning activities for new product development projects through all phases of the product development lifecycle.
• Collaborate with product development and manufacturing engineering on product and process design.
• Ensure design control requirements are met, including compliance of the design history file, and support transition of the design project into commercial operations.
• Assist in risk management activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as failure modes and effects analysis, fault tree analysis, and hazard assessment.
• Contribute to validation planning for new and existing processes.
• Provide validation, sampling, and statistical analysis support to other functions in the organization.
• Assist in quality issue resolution (deviation, nonconformance, out of specification, CAPA and complaints) by applying root cause methodologies.
• Assist in the design and implementation of inspection methods, equipment, acceptance criteria and sampling plans.
• Assist in change management activities.
• Collaborate with supply chain partners to assure quality of product.
• Initiates or assists in cost reductions of product inspections.
• Provide support during internal or external audits.
• Create, maintain, and support quality system processes and procedures.
• Prepare reports and presentations by collecting, analyzing, and summarizing data, and making recommendations.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
• Perform all other duties assigned by Supervisor

Location

913 Industrial Drive Place, Vandalia, OH 45377

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Benefits/Compensation

This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$61,194-$76,491 USD

Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us