Engineer I - R&D
Össur
Foothill Ranch, CA
Thank you for your interest in Össur. The most important resource of Össur is its staff. At Össur, we value our extensive skills and knowledge base and naturally we nurture a spirit of innovation. With wide-ranging roles involved in our business, Össur is keen to attract talented individuals and accomplished team players, who are ready to contribute to the achievement of our goals.

Position is based at the Össur Americas Bracing & Support division. This engineer will be responsible for assisting in maintaining and improving existing product and in the development of projects from inception into production. Duties will include product design, preparing prototypes and conducting all qualification and verification testing while working in a multidisciplinary team.
This candidate will also prepare product specifications, conduct design reviews and prepare all documentation in compliance with Medical regulatory standards.

Job Description:
Responsibilities:
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 required ability.
Develop specifications from general description and draw sketches of a part or product to be fabricated. Design product according to the Design Criteria and ISO standards. Design for manufacturing (DFM).
Develop test methods, protocols, fixture designs and processes to compare product designs and verify final designs.
Apply engineering concepts in mechanical designs per GDPs into practicable engineering design and final installation drawings. Demonstrate a high level of competence in 3D modeling and generate complex 3D models and drawings of mechanical systems in order to meet quality and content requirements under the guidance of engineering management.
Perform all design tasks in accordance with Quality Assurance Program requirements as applicable. Prepare risk analysis and Failure Modes/Effects Analyses (FMEA). Inspect First Article (FA) parts to drawing specs. and prepare reports.
Schedule work to meet or beat project schedules.
Coordinate and ensure timely and quality communications with the Engineering staff & management, sales and marketing, manufacturing, and vendors of project requirements to clarify and resolve problems. Communicate with vendors and manufacturing on product design and manufacturing.
Have excellent overall knowledge of component engineering, mechanical or biomedical.
Experienced with test method design, fixturing, protocols, processes, bio-mechanical testing for comparison of products, and verification of designs. Electronics/ actuators for cyclic testing.
Current knowledge or ability to learn good skills in the use of GDT, Tolerance Stack-Up analysis, Mold Flow and Stress Analysis/FEA among many engineering skills, and good knowledge of performance textile/softgood design and seam/sewing techniques are a plus.
Able to confer with production personnel or others to resolve fabrication, machining and assembly problems.
Able to work collaboratively in a team environment & excellent written and oral communication skills with ability to solicit cooperation and support of individuals across departmental boundaries.
Demonstrate a high aptitude for out of box thinking and a high level of creativity.
All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific.
All training related to the quality management system is done in accordance to the Training Management Process.
Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company’s representative at all times.
Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.
Perform other duties as requested
Adhere to Company’s safety policies
Adhere to Össur Company Values – Honesty – Frugality – Courage

Qualifications:
BS degree in Mechanical or Bio-Medical Engineering
Three or more years experience in the medical device industry is a Plus.
Experience with SolidWorks Version 2008 to 2018 is a Plus
Proficient in MS office such as Word, Excel and PowerPoint. Basic understanding of MS Project.
Thorough knowledge of ANSI Drafting standards
Ability to travel domestically and internationally if required.