Product Engineering Manager

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.

Position Objective:

• Coordinate and manage engineering support to: meet product performance specifications and manufacturing goals; develop and maintain manufacturing documentation and labeling; troubleshoot and resolve production problems; develop and support production outsourcing and raw material vendors.
• Work with production and other support groups to develop, qualify and implement new or improved products and processes.
• Coordinate product engineering responses to Non-Conformances, CAPA, complaints, technical questions and regulatory reviews.

Responsibilities:

• Foster a culture of engineering excellence and establish a work environment that inspires continuous improvement.
• Provide coaching, guidance, and performance feedback to engineers. Facilitate professional development to enhance employee growth opportunities and output.
• Spearhead engineering efforts to resolve product issues and challenge team members to develop workable, innovative solutions.
• Manage the workflow of engineers within the scope of assigned projects to ensure project plans adhere to agreed-upon timelines and budget. Coordinate with Operations to ensure correct project prioritization.
• Delegate and manage tasks among team members as appropriate to their skill level and risk to the assignment.
• Coordinate site cross-functional Lean Six Sigma teams to enhance quality and efficiency of manufacturing processes.
• Develop high-level plans, schedules, resource assignments, and budgets for larger production projects that reduce product cost, improve product quality and increase production capacity.
• Build a close working relationship with peers in other departments to implement best practices and optimize inter-departmental operations.
• Lead and coordinate projects for design changes and line extensions, including validations, biocompatibility, shelf life and other design verification and validation tests. Maintain and ensure Design History Files (DHF) and Device Master Records (DMR) are current and correct.
• Responsible for development and execution of required product performance tests both internally and at outside laboratories.
• Manage engineering support to identify and support production outsourcing and raw materials vendors, including qualifications associated with vendor changes.
• Oversee development and maintenance of manufacturing documentation by engineering to include product specifications, product drawings, procedures, labeling and packaging.
• Coordinate product engineering responses for Non-Conformances, CAPA, complaints, technical questions and regulatory reviews.
• Provide technical support for analysis of field failures and customer returns
• Ensure employees are trained to do their work and their training is documented. Generate and execute departmental training plans to include product design, CAD modeling, labeling software, lean manufacturing and statistical analysis.
• Conduct performance reviews and recommend appropriate salary increases for personnel within the department.
• Maintain the highest ethical standards, even when challenged from above.
• Demonstrate and ensure adherence to Artivion Core Values of Collaboration, Results-Driven and Customer Focused.

Other responsibilities as assigned.

Key Result Areas:

1. Prompt resolution of product and labeling issues to ensure production continuity.
2. Continuous process improvement, improve product yield and improve product quality.
3. Achieve operations cost savings targets.
4. Company goals/projects met.
5. Engineering staff development.

Qualifications:

• Bachelor's Degree in Engineering or related field.
• 5-8 years' experience within medical device or related manufacturing operation, which includes direct support for commercial product.
• Previous supervisory or management responsibility preferred.
• Excellent teamwork skills and motivation to help others.
• Must have excellent oral and written communication skills.
• Lean Six Sigma Green Belt Certified (Black Belt preferred).
• Comprehends Mechanical drawings for Product and Components.
• Inherent vision for production improvements.
• Ability to manage and prioritize multiple tasks to completion.
• Ability to screen, interview, and select appropriate personnel.
• Ability to make decisions quickly in stressful situations.
• Ability to anticipate needs and ensure they are planned for.
• Ability to motivate staff to achieve excellence.

Benefits:

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.