Job Description:
Determines the optimal manufacturing methods and processes for the production of medical products under cGMP and FDA regulatory standards. The incumbent in this role is responsible for the design and development of manufacturing processes for legacy and new medical products. This includes analyzing engineering documentation, establishing manufacturing methods and processes, creating conceptual sketches, and completing the procurements, build, and procurement of tooling and fixtures. Desires for continuous improvement and implementation of new methods that realize higher quality and improved customer experience.
Become the hands-on, subject matter expert on equipment, processes, and products at the Nobel Biocare Yorba Linda facility.Work with the global team on new product introductions and be accountable for local actions and tasks to ensure that products and initiatives are introduced on time, problems are minimized and communicated quickly, and products are manufactured efficiently.Serve as a point of contact for production and machine center managers to resolve product, process, or equipment issues.Perform GAP analysis and justifications for process improvements.Participate in the design, specification development, selection, and procurement of manufacturing and process equipment.Perform risk evaluations and pFMEA analysis on legacy and future manufacturing processes.Plan and perform process validations and equipment qualifications (IQ/OQ/PQ) on new products and processes.Manage tasks and remain on track to ensure that new equipment and processes are released to production on time.Facilitate changes in the factory through the ECO/MCO process.Support EBS and contribute to Kaizen events to reduce downtime and improve yield, production output, productivity, and quality.Act as a key contributor to resolving CAPAs.Validate outside suppliers and outside tooling (e.g., molds located at a supplier’s facility)Generate technical reports.Conduct DOE and apply statistical strategy to confirm acceptable conditions.Resolve technical engineering issues related to components and manufacturing.Identify opportunities to improve equipment reliability and carve out a path to implement changes in a medical manufacturing setting.Job Requirements:
Requirements
Bachelor’s degree in an engineering discipline or equivalent. Additional education or certifications are a plus. Preference for chemical engineering or chemical background/experienceKnowledge of process validation and production transfer of new products in a regulated industryMinimum of 2 years professional engineering work experience as well as experience working in a medical device (or similarly regulated) manufacturing environment.#LI-MC1
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Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
-Operating Company:
Nobel BiocareEnvista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.