Product Development Engineer

Envista Holdings Corporation; Los Angeles (CA); On-site; USD 98,700 - 120,700; Full time

Job summary

Envista Holdings Corporation is seeking a Product Development Engineer to execute core elements of New Product Development for surgical implants, prosthetics, and instruments. You will participate in concept development, design verification/validation, and design transfer to production with cross-functional teams.

This on-site role is based in Thousand Oaks, CA, 5 days a week. You must hold a Bachelor’s degree in Mechanical or Biomedical Engineering, and have at least 2 years of experience in

Qualifications

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering or equivalent required.
• Minimum 2 years’ experience in product development; medical device or regulated industry 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.

Responsibilities

• Generate product development documentation ensuring compliance with internal SOPs, ISO 13485 and FDA 21CFR Part 820.30.
• Conduct risk management activities (FMEA) and document results ensuring ISO compatibility (ISO 14971).
• Conduct biocompatibility and sterilization evaluations with appropriate documentation (ISO 10993-1, ISO 11737).
• Perform Finite Element Analysis as needed.
• Carry out statistical analysis for test results and sample size justification.
• Review part dimensions, materials, and tolerances to ensure overall product integrity.
• Review and approve drawings applying GD&T per ASME Y14.5.
• Develop engineering protocols/reports, initiate Change Orders, and prepare documentation.
• Assist in coordinating new product introductions with cross-functional teams.
• Coordinate with vendors and project participants to ensure timely action items.

Skills

3D CAD modeling

Technical writing

Attention to detail

Education

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

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 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.

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 .