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
Participates in teams and is responsible for engineering deliverables assigned.
Effectively communicates with immediate working team and direct supervisor.
Presents to small internal audiences.
Creates and/or follows test protocols based on known methodologies. Designs experiments and summarizes results for peer review.
Creates and updates designs, drawings and models within CAD/Windchill applying GD&T principles.
Performs reviews of prints and 3D models for their quality and correctness prior to release.
Performs 1D tolerance stack analysis.
Applies Finite Element Analysis (FEA) principles and analysis to understand basic design risks and failure modes.
Applies basic Root Cause Analysis tools (RCA) to investigate issues and prepare summary for peer review.
Creates Engineering Change Orders (ECO's) and manages through completion.
Reviews Risk Management Reports (RMR's) with ability to identify impacts of potential design changes/applications.
Follows and works within Acumed's Design Control process and framework.
Utilizes SAP for applicable engineering functions.
Understands and conducts work practices in compliance with applicable ISO and CFR regulations/guidance.
Understands and applies basic statistical tools to evaluate and derive conclusion from test data.
Investigates and develops working knowledge of at least one technical specialty area assigned by manager.
Researches and understands clinically relevant content to support assigned projects.
Researches and understands competitive products and techniques to support assigned projects.
Understands general anatomy and terminology to support assigned projects.
Participates in Cadaver Labs for internal product development as needed to support assigned projects.
Completes the duties described in the Quality Manual.
Qualifications
Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent, Entry level*
Read, write and speak English effectively to understand and complete all documentation and can write clean and concise business correspondences (i.e. emails)
Ability to give presentations to small audiences
Proficiency with Microsoft Office software
Ability to manage multiple tasks under supervision
Knowledge of mechanical and/or biomechanical testing preferred
Knowledge of GD&T principles, 1D tolerance stack analysis and their applications preferred
Knowledge of FEA principles and application preferred
Ability to conduct small literature searches
Basic knowledge of 3D/2D software, print creation and/or modeling.
Basic understanding of human anatomy, Musculoskeletal system preferred
Basic knowledge of applicable ISO and CFR regulations preferred
Working knowledge and ability to apply basic statistical tools/models.
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 .
