Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.
Product Engineer 1, Sustaining
The Product Engineer, Sustaining is responsible for products after development is completed and when they are released for commercialization. This includes supporting manufacturing, quality improvements, product analysis on field complaints, document Remediation, biocompatibility of raw materials and final products, additional testing required by regulatory bodies for follow on regions and supporting product training to surgeons as needed. When needed, the Product Sustaining Engineer also participates on new product development teams and/or product update and extension projects. All of these efforts involve research, planning, idea creation and realization, concept development, specification generation, testing and validation protocols, as well as effective communication with team members, management, and customers.
Duties/Responsibilities
Manages and delegates tasks to entry-level engineers, product designers, and other junior staff.
Leads medium to large cross functional projects.
Presents to large cross-functional audiences and management teams and influences key decisions/stake holders.
Builds good collaborative relationships with HCP's and sales personnel.
Defines test methods, protocols and complex experimental designs and fixtures.
Independently manages external vendors.
Establishes mechanical, Biologic and clinical correlations for test methods and designs as needed to support assigned projects.
Leverages CAD/Windchill experience to create reusable design elements and standards.
Applies advanced Finite Element Analysis (FEA) principles for complex risk and failure mode analysis.
Utilizes various Root Cause Analysis (RCA) tools for complex issues, leads a team to investigate and resolve.
Works with Quality to define and co-author design risk inputs to Risk Management Report (RMR).
Acts as an independent reviewer for various design control activities.
Understands Acumed project funding process and provides design/engineering inputs. Evaluates and provide impacts of design changes to ROI and Project Management.
Reviews and verifies statistical analysis performed by lower level engineers or designers.
Advises and provides technical insight/guidance on 2 or more technical specialty areas to the engineering community.
Interprets and applies clinical research data and relevancy to IOVV criteria and user needs as needed to support assigned projects.
Organizes and conducts cadaver labs with surgeons as needed to support assigned projects.
Qualifications
Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent with 2 or more years' experience*
Demonstrated ability to communicate clearly, effectively with teammates and managers
Ability to lead teams on small projects
Ability to write test protocols & reports and conduct testing under limited supervision
Applied knowledge of 3D/2D software, ability to model and create drawings of moderate complexity for plates, screws and or instruments
Knowledgeable and able to apply Level 1 & 2 GD&T principles to technical drawings
Knowledgeable and able to apply basic FEA analysis to mitigate design failure modes
Proficient in creating and managing ECO's through completion
Knowledgeable and ability to apply basic root cause analysis techniques to solve issues
Ability to read and understand medical journal articles and present data effectively to peers and perform clinical summaries and write clinical data reports.
Ability to read and understand patents.
Knowledgeable and able to apply and navigate Acumed's Design control process
Completion and certification for Level 100 and 200 Anatomy and product training
Demonstrated understanding of Anatomy and clinical issues in indications for assigned projects
Knowledgeable in at least one technical specialty area
Ability to conduct in depth literature searches
Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.
As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net .
