Product Development Engineer

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

Job summary

Envista Holdings Corporation seeks a Product Development Engineer to drive New Product Development for surgical implants, prosthetics, and instruments. You will contribute to concept development, design, verification, validation, and transfer to production, collaborating with cross-functional teams.

On-site in Thousand Oaks, you will generate documentation, conduct risk assessments (FMEA), and perform biocompatibility and sterilization evaluations while ensuring ISO 13485 and FDA 21 CFR 820.30

Qualifications

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• Minimum 2 years’ experience in product development in a regulated industry.
• Proficient in 3D CAD modelling and engineering drawings (SolidWorks or similar).
• Strong technical writing skills for requirements, specs, test protocols and reports.

Responsibilities

• Execute key elements of New Product Development for surgical implants and devices.
• Support concept development, design, verification/validation, and transfer to production.
• Create and review engineering documentation and participate in design reviews.
• Coordinate with cross-functional teams on project activities and timelines.

Skills

Technical writing

Quality systems

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

GD&T

FMEA

Statistical analysis

Job description

## Product Development EngineerApplylocations: United States of America, California, Thousand Oaks: United States of America, California, Los Angelestime type: Full timeposted on: Posted Todayjob requisition id: R5026833**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.#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