Product Development Engineer

Envista Holdings Corporation; Westlake Village (CA); On-site; USD 99,000 - 121,000; Full time

Job summary

Envista Holdings Corporation is seeking a Product Development Engineer to advance new surgical implants, prosthetics, and instruments from concept through design transfer to production. You will work on verification, validation, biocompatibility, sterilization, and cross-functional projects on site in Thousand Oaks, CA.

The role requires a mechanical or biomedical engineering background, 2+ years in regulated product development, and proficiency in 3D CAD and GD&T.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 2+ years in product development; medical device experience preferred.
• Proficient in 3D CAD and Engineering Drawings (SolidWorks or similar).
• Strong technical writing for requirements, specs, protocols and rationales.

Responsibilities

• Generate development documentation meeting ISO 13485 and FDA 21 CFR 820.30.
• Conduct risk management (FMEA) per ISO 14971 with documentation.
• Perform biocompatibility and sterilization evaluations per ISO 10993-1/11737.
• Carry out Finite Element Analysis when needed.
• Run statistical analysis for test results and sample size rationalization.
• Review parts dimensions, materials, tolerances and GD&T per ASME Y14.5.
• Develop protocols/reports, initiate Change Orders, and document engineering activity.
• Coordinate with vendors to ensure timely action items.

Skills

3D CAD modeling

Engineering Drawings

Technical writing

FMEA

Statistical analysis

GD&T knowledge

Education

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

Finite Element Analysis (FEA)

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.
• Develop engineering protocols/reports, initiates Change Orders (CO) and prepare engineering documentation.
• 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.

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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. $98,700 - $120,700 Operating Company: Implant Direct Envista

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 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.

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile.

Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.