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The Product Development Engineer will execute new product development for surgical implants and instruments, including design, verification, and validation. They will collaborate with cross-functional teams to ensure compliance with regulatory standards and manage documentation throughout the product lifecycle.
Requirements
Candidates must hold a bachelor's degree in Mechanical or Biomedical Engineering with at least 2 years of experience in product development within a regulated industry. Proficiency in 3D CAD modeling and strong technical writing skills are essential for this role.
Full job description
Job Description:
The Product Development Engineer is engaged in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market. In this role, you will participate in the following: Concept Development, Design & Development, Design Verification & Validation, and Design Transfer to production. You will serve as a core team member of the Design Engineering team, while partnering with cross-functional experts on projects. You will participate in the planning and execution of Design Verification & Validation activities and participate in activities including product & packaging performance evaluation, Biocompatibility assessments, Usability Studies and Sterilization Validation assessment.
This role would be on-site 5 days per week in Thousand Oaks, CA
Job Requirements:
ESSENTIAL DUTIES:
Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30.
Conduct risk management activities (FMEA) and document results ensuring compliance with internal procedures and ISO-14971.
Conduct biocompatibility and sterilization evaluations and generate documentation ensuring compliance with internal procedures, ISO 10993-1 and ISO 11737.
Perform Finite Element Analysis if needed.
Perform statistical analysis for test results and sample size rationalization.
Review dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines.
Review and approve drawings, applying knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
Assist in project activities to coordinate new product introductions.
Coordinate with vendors and other project participants to ensure timely response to action items.
MINIMUM REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree in Mechanical Engineering or Biomedical Engineering
Minimum 2 years’ experience in product development; medical device or another highly regulated industry is highly preferred
Proficient in 3D CAD modeling and Engineering Drawings (SolidWorks or similar).
Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.
#LI-RJ1 IND123
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.
$98,700 - $120,700
Operating Company:
Implant Direct
Envista 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.
Related keywords
Product DevelopmentSurgical ImplantsProstheticsISO 13485FDA 21CFR Part 820.30Risk ManagementFMEAISO 14971BiocompatibilityISO 10993-1ISO 11737Finite Element AnalysisStatistical AnalysisGD&TASME Y14.5Change Orders
Partnering with dental professionals to improve lives.
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
2019
Headquarters
Brea, California
LinkedIn followers
49,520
Total funding
$885M
Envista is a global leader in the dental industry, uniting more than 30 trusted brands—including DEXIS, Kerr, Nobel Biocare, and Ormco—under one mission: partnering with dental professionals to improve lives.
With a heritage of category-defining innovation, our brands have shaped modern dentistry: Nobel Biocare introduced the first dental implant, Ormco pioneered wire-and-bracket orthodontics, Kerr has supported clinicians for over 135 years, and DEXIS helped advance CBCT imaging.
Guided by a culture of customer centricity and continuous improvement through the Envista Business System, we deliver a comprehensive portfolio of technologies, consumables, and services that empower clinicians to provide confident, efficient care—today and for the future.
Learn more at www.envistaco.com.
Offices: 200 S Kraemer Blvd, Brea, California 92821, US · Prague, CZ · San Jose, CR · Suzhou, CN
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