Sr. Manager, Manufacturing Engineer 5/5/2020
Santa Rosa, CA
JOB DESCRIPTIONAPPLY OVERVIEW
Sr Manager will be responsible in forming and leading the Engineering team on projects to create manufacturing effectiveness.
In this role, Sr Manager will participate in and provide Engineering leadership for project phases including conception, planning, execution and successful implementation of projects and activities such as production line duplications, process improvements, V&V, as well as adoption of mechanization and automation. Also, the role will lead the Engineering team to ensure all team commitments and project contract metrics are met and communicated in a timely manner. This position is expected to perform independently with little tactical input and is accountable for the outcome of all projects while leading and collaborating across other functional departments.
* Directly responsible in leading, forming, mentoring, developing and coaching engineering team on meeting/exceeding performance expectations.
* Be the voice of Engineering and work closely with functional stake holders, managers, and teams to develop holistic and detailed plans and roadmaps for project execution.
* Communicate the management goals and strategy and disseminate pertinent data and information required for all engineers to successfully perform in their respective roles and to the success against business goals.
* Lead Engineering team to solve complex problems including, but not limited to, those related to process, equipment, documentation, equipment validation, IQ/OQ/PQ and manufacturing ramp up.
* Allocates resources to support sustaining and NPD activities, manufacturing improvement initiatives and problem/issue resolution.
* Provides direction and establishes priorities concerning manufacturing processes, programs and procedures that are consistent with all business priorities, priorities, and procedures.
* Can analyze daily/weekly/monthly KPI: Safety, Quality/Scrap, Efficiency, Volume and Productivity.
* Understands the manufacturing plans with Supply Chain, Operations, Finance, and Engineering goals and objectives.
* Manages the development, implementation and maintenance requirements of processes and equipment for manufacturing of products to achieve cost effectiveness and product quality.
* Develop and establish improved controls to provide accurate information as to accomplishments, progress, performance, capabilities in controlling and savings.
* Design and develop manufacturing processes for new products and/or changes to existing products
* Design and develop fixtures and tooling for manufacturing process
* Develop and execute process validation protocols (IQ/OQ/PQ)
* Analyze process data and make decisions/recommendations relating to process capability and DFM. Works with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved.
* Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
* Contributes to improvement of Product Development and other company processes / procedures.
* Maintains accurate documentation of concepts, designs, and processes.
* Maintains current knowledge of medical, technical, and biomedical developments as related to company products.
* Strong communication, project management and influencing skills required.
* Strong interpersonal and influence skills including efficient collaboration, effective negotiation, timely conflict resolution, and creative problem solving of difficult situations such as resource constraints, ambiguous/conflicting requirements, and other roadblocks.
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
* Must possess courage and confidence in managing risks and making decisions that will likely have a large impact on project and/or organizational objectives.
* Has the ability to use moderate to advanced statistic techniques when analyzing data and make rational and logical decision base the that analysis
* Applicable knowledge of Minitab, JMP, or other statistic tools
* Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
* Manages and accountable to engineering staff and projects of diverse scope in which analysis of data requires evaluation of identifiable factors.
* Requires a Bachelor of Science degree in Engineering or related technical degree (i.e. physics or mathematics)
* Masters preferred
* 12+ years with a bachelor s degree and a Master s degree or 10+ years with a PhD or MD, of directly relevant experience with Endovascular products, medical device development or field. Experience with FDA, ISO, GMP and design control regulation.
* 10+ years experience as an Engineering Manager. Must have managed Supervisors/Managers, as well as managed a team of at least 10 people.
* Strong understanding of Design Control and Process Validation required.
* Strong understanding of Lean Manufacturing and Design for Manufacturing required. Black Belt certification preferred.
PMP Certification a plus.
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.