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
Bachelors 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.