Senior Manufacturing Engineer I

Integra LifeSciences

Irvine, CA

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JOB DETAILS

SALARY

$81,650–$112,700 Per Year

SKILLS

Adobe Illustrator, Bill of Materials (BOM), Calendar Management, Communication Skills, Corporate Compliance, Corporate Policies, Design Verification, Documentation, Electrical Engineering, Electricity, Electronics, Experiment Design, FDA (Food and Drug Administration), Healthcare, Machine Tool, Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Marketing, Mechanical Engineering, Medical Equipment, Medical Products, Metal Joining, Microsoft Excel, Microsoft Word, Minitab, Presentation/Verbal Skills, Problem Solving Skills, Process Management, Process Validation, Product Development, Product Management, Product/Service Launch, Project Schedule, Project/Program Management, Regulations, Research & Development (R&D), Resume Search, Six Sigma, Soldering, SolidWorks, Standards of Care, Test Plan/Schedule, Testing, United States Department of Energy (DOE), Validation Testing, Vendor/Supplier Relations, Writing Skills

LOCATION

Irvine, CA

POSTED

30+ days ago

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.

KEY 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.

QUALIFICATIONS & 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

PREFERRED QUALIFICATIONS

+ 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

Salary Pay Range:

$81,650.00 - $112,700.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

About the Company

Integra LifeSciences

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