Senior Manufacturing Engineer I

Integra LifeSciences•Irvine, CA

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Manufacturing Operator I will manage a wide variety of technical tasks and projects in the development of new products and manufacturing processes. They will be a leader within the New Product. Introduction (NPI) and Lifecycle Management (LCM) group and a key member of Acclarent’s medical device product development teams.

Requirements

Bachelor’s degree in engineering or related discipline
At least 4 years of experience in an FDA-regulated industry
Demonstrated knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO & MDD)
Proficient with Microsoft Word, Excel and Project
Able to design process tooling on Solidworks
Problem solving skills

Nice To Haves

Bachelor’s degree in mechanical or electrical engineering
Experience in medical device manufacturing
Proven application of statistical techniques and Design of Experiment (DOE)
Hands on and being able to work in the lab
Verbal and written communication skills, project management, problem solving, six sigma and process excellence tools/methodologies, presentation skills, training/education methodologies (Solid works, Excel, Minitab, Adobe Illustrator).
Six sigma and process excellence tools/methodologies
Strong written and verbal communication skills with individuals and groups at all levels
Good presentation skills to deliver speeches and/or presentations effectively to a variety of audiences

Responsibilities

Contributes directly to the development of new processes and techniques to ensure that products are high quality, low cost and meet customers’ needs.
Serves as a technical interface at Acclarent between the manufacturing and materials, R&D, quality, regulatory and marketing organizations.
Designs, develops and refines processes, including scoping and challenge testing of outputs .
Accurately and efficiently translates designs into documented processes and procedures.
Participates in the creation and execution of engineering build packages.
Design fixtures and tooling using Solidworks and qualifies equipment and fixtures.
Plans, schedules and completes projects in an aggressive manner.
Manages product/process changes and designs/develops new products and processes.
Solve production process problems.
Familiar with plastic and metal joining processes.
Writes test protocols and reports for design verification/process validation, completes testing and transfers to manufacturing.
Completes all required production documentation, including Manufacturing Process Instructions (MPIs), Lot History Records (LHRs), Bills of Material (BOMs).
Interface with External manufacturers and suppliers.
Lead External manufactures in solving production process problems.
Directs activities of technicians, as needed.
Understand basic electronics.
Hands on and able to do hand soldering for electrical and mechanical connections.
Other responsibilities as required or assigned by manager.
Responsible for communicating business related issues or opportunities to the next management level..
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage staff, 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 Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.