ACE Partners
Manager of Product Engineering - $140k - $160k
Bonus + Equity + Unlimited PTO
Austin TX
US Citizen/Green card holders only
A leading medical device company specializing in innovative solutions for complex cardiovascular Medical Devices, are seeking a talented Engineering Manager. With a global presence and a commitment to advancing healthcare, our client serves professionals in over 100 countries.
Objective
- Coordinate and manage engineering support to ensure product performance, meet manufacturing goals, and maintain documentation and labeling.
- Collaborate with production and support teams to develop, qualify, and implement new or improved products and processes.
- Lead responses to non-conformances, CAPA, complaints, technical inquiries, and regulatory reviews.
Responsibilities
- Foster a culture of engineering excellence and continuous improvement.
- Provide coaching, guidance, and performance feedback to engineers, supporting their professional development.
- Lead engineering efforts to resolve product issues and drive innovative solutions.
- Manage project workflows to ensure adherence to timelines and budgets, coordinating with Operations for proper prioritization.
- Delegate tasks based on team members’ skills and project needs.
- Lead cross-functional Lean Six Sigma teams to enhance manufacturing quality and efficiency.
- Develop plans, schedules, resource assignments, and budgets for production projects aimed at reducing costs, improving quality, and increasing capacity.
- Build strong inter-departmental relationships to implement best practices and optimize operations.
- Oversee design changes, line extensions, validations, biocompatibility, shelf life, and other verification/validation tests, ensuring accurate Design History Files (DHF) and Device Master Records (DMR).
- Manage product performance testing, both internally and at external laboratories.
- Support production outsourcing and vendor management, including qualifications for vendor changes.
- Oversee development and maintenance of manufacturing documentation, including specifications, drawings, procedures, labeling, and packaging.
- Provide technical support for analyzing field failures and customer returns.
- Ensure employee training is documented and execute training plans covering product design, CAD modeling, labeling software, lean manufacturing, and statistical analysis.
- Conduct performance reviews and recommend salary adjustments.
- Uphold high ethical standards and company core values of Collaboration, Results-Driven, and Customer Focused.
- Other responsibilities as assigned.
Key Result Areas
- Prompt resolution of product and labeling issues to ensure production continuity.
- Continuous process improvement, enhanced product yield, and improved quality.
- Achievement of cost savings targets.
- Successful completion of company goals and projects.
- Development of engineering staff.
Qualifications
- Bachelor’s Degree in Engineering or a related field.
- 5-8 years of experience in medical device or related manufacturing, including direct support for commercial products.
- Previous supervisory or management experience preferred.
- Excellent teamwork and motivational skills.
- Strong oral and written communication abilities.
- Lean Six Sigma Green Belt certification (Black Belt preferred).
- Ability to interpret mechanical drawings for products and components.
- Vision for production improvements.
- Strong multitasking and prioritization skills.
- Ability to screen, interview, and select personnel.
- Quick decision-making in high-pressure situations.
- Proactive in anticipating and planning for needs.
- Ability to motivate teams to achieve excellence.