Job Description
Job DescriptionSalary: $130k+/yr DOE
OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr Product Development Engineer (Mechanical) responsible for the development of new products, transitioning products from design phase to production, and providing support for all products in production. This is a hands-on role with work performed in office for effective collaboration and communication.
You will:
- Provide end-to-end design and development of new products per companys design control procedures and QSR requirements in accordance with plans and milestones.
- Develop test strategies, plan and facilitate testing. Execute and document product verification and validation testing for compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements and related specifications.
- Work closely with suppliers to collaborate on DFM recommendations to optimize cost and quality.
- Develop new suppliers, new manufacturing procedures and product enhancements.
- Work with manufacturing and quality personnel to develop inspection procedures and processes for new products in compliance with the companys quality system and business goals.
- Transition products from concept to design phase through V&V to production.
- Communicate progress to project leadership and cross-functional teams in periodic status meetings/reports.
- Work closely with Quality, Regulatory, Marketing, Sales and Customer Service to support the product in the field, manage the analysis of products returned from the field, and implement product improvements.
- Work closely with cross-functional teams, surgeons and other customers to deliver solutions to defined unmet needs.
You need:
- Proficiency in CAD working on complex designs and creation of associated drawings / GD&T.
- Excellent attention to detail, producing high quality output.
- Ability to work as a collaborative team member as well as independently.
- Apply sound judgment when making decisions and communicating with peers and management.
- Identify and resolve problems utilizing sound engineering principles and concepts.
- Knowledge of FDA, ISO, GMP and design controls.
- Ability to develop and execute verification, validation, and qualification protocols.
- Excellent written and verbal communication skills.
- Flexibility and strong organizational skills with ability to prioritize multiple tasks.
- Proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint).
- Experience in orthopedic devices and instruments a plus.
- Cadaver Lab experience a plus.
- BS/BA degree in Mechanical / Biomedical Engineering and 8 years of experience with at least 5 years in direct medical device development OR 20 years of relevant experience.
We offer:
- Competitive compensation including bonus and equity
- Opportunities for career advancement
- Full benefits package
- An evolving, engaging culture and workplace
- Nominated by our employees as a Top Place to Work in Orange County!
It is an exciting time at OrthAlign - make your next career move with us!
Please note that we are unable to provide any type of sponsorship at this time.
No recruiters, please.