Manager, Technical Lifecycle Management

Jobtailor; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor in Irvine, CA, seeks a senior Life Cycle Management leader to drive cross-functional programs for medical device products, processes, and manufacturing equipment. You will apply Six Sigma and lean methodologies to deliver high-quality improvements under regulated design controls.

You will mentor teams, coordinate with R&D, manufacturing, QA, and supply chain, manage complex problems, and ensure strict compliance with ISO 13485 and related regulatory requirements while controlling

Qualifications

• Bachelor's degree in Engineering required; advanced degree preferred.
• Minimum of 10 years professional experience.
• Highly regulated industry knowledge; medical device industry experience preferred.
• Previous supervisory experience required.
• Familiarity with ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications related to medical devices.
• Six Sigma Process Excellence knowledge; Black Belt certification preferred.
• Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements.
• Leadership experience managing technical relationships with external suppliers and OEMs.
• Strong project management skills (Microsoft Project, FPX and/or other project management tools).
• Supplier development skills.
• Strong communication, team building, and cross-functional coordination skills.

Responsibilities

• Drive the execution of Life Cycle Management projects in a cross-functional setting.
• Work under consultative direction toward predetermined long-range goals.
• Work on unusually complex problems and provide solutions which are highly innovative and ingenious.
• Apply broad scientific and engineering knowledge to the development and improvement of medical device products, processes, and manufacturing equipment as well as validations.
• Collaborate with cross-functional teams to determine root cause, develop mitigations and CAPAs for manufacturing issues.
• Exercise judgment within defined practices to select methods for solutions.
• Demonstrates leadership abilities within and across functions.
• Demonstrates people skills to lead engineering teams.
• Evaluate manufacturing processes / products with R&D, NPI, Sourcing, QA, MFG and Finance to lead quality/productivity improvements.
• Utilize Six Sigma and lean tools and methodologies.
• Design and develop troubleshooting guides and decision-making matrices for standard methods.
• Provide technical training and guidance to engineering personnel.
• Ensure project quality including data interpretation, reporting and regulatory compliance.
• Evaluate progress against goals and objectives; recommend major procedural changes.
• Maintain documentation of concepts, designs, drawings, processes, test methods, data analysis and rationales.
• Provide technical support for suppliers, vendors, and consultants; include supplier visits and process improvements.
• Develop proposals and cost estimates for project/process improvements.
• Provide guidance and direction to direct reports and project teams.
• Communicate business-related issues or opportunities to management.
• Ensure adherence to Health, Safety and Environmental practices and regulatory requirements.
• Ensure personal and company compliance with regulations and internal policies.
• Performs other duties as needed.

Skills

Leadership

Cross-functional coordination

Project management

Six Sigma / Lean

Strong communication

Supplier development

Problem solving

Team building

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Microsoft Project

FPX

Job description

• Drive the execution of Life Cycle Management projects in a cross-functional setting.
• Work under consultative direction toward predetermined long-range goals.
• Work on unusually complex problems and provides solutions which are highly innovative and ingenious.
• Apply broad scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.
• Work with cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for processes and manufacturing related issues.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Demonstrates leadership abilities within and across functions.
• Demonstrates people skills to lead engineering team.
• Evaluate manufacturing processes / products and collaborate with R&D, NPI, Sourcing, QA, MFG and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs.
• Utilize the application of six sigma and lean tools and methodologies.
• Design and develops troubleshooting guides and decision‑making matrices to ensure the standard application of methods in the resolution of process/ manufacturing technical issues.
• Provide technical training and guidance to engineering personnel.
• Ensure the quality of projects including design, data summary and interpretation, report and manuscript preparation and review compliance to applicable regulations.
• Evaluate progress and results against goals and objectives.
• Recommends major changes in procedures or objectives.
• Maintain accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales.
• Provide technical support for outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements.
• Work out proposals and cost estimates of project/process related costs or cost improvements.
• Provide guidance and work direction to direct reports and related project team members.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.
• Performs other duties assigned as needed.

Requirements

• A minimum of Bachelor’s degree in Engineering is required.
• An advanced degree in preferred.
• A minimum of 10 years of professional experience is required.
• A highly regulated industry knowledge is required; Medical device industry experience is preferred.
• Previous supervisory experience is required.
• Familiarity with ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
• Six Sigma Process Excellence knowledge and Black Belt Certification is preferred.
• Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements is required.
• Leadership experience in managing technical relationships with external suppliers and OEMs is required.`
• Strong project management skills required (Microsoft Project, FPX and/or other project management tools).
• Supplier development skills.
• Strong communication, team building, and cross‑functional coordination skills.