Acumed
  • 02-Feb-2018 to 03-Apr-2018 (PST)
  • Product Development - Packaging
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Time Off, Floating Holidays, Costco Membership Sponsorship, TriMet Pass Sponsorship, Tuition Reimbursement Program, Summer Hours and more!


Job Overview:
The Product Development Engineer designs, and tests sterile and non-sterile packaging solutions that ensure safe and effective presentation of Acumed products during surgery and protection of products during transport and storage. These systems include customized surgical tray systems that facilitate product reprocessing and re-sterilization as well as sterile packaging that maintains sterile barriers throughout the product lifecycle. Responsibilities include 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. The Product Development Engineer also supports packaging solutions after development by collaborating with cross-functional groups when manufacturing and quality improvements or other activities are needed.

Duties/Responsibilites:

  • Participates in teams and is responsible for engineering deliverables assigned.
  • Effectively communicates with external vendors to move projects forward.
  • Participates in events to gather input from hospital staff and consultants.
  • 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 departmental best known methods to evaluate products and determine necessary testing.
  • 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.
  • Creates and updates content for IFU's.
  • Reviews Risk Management Reports (RMR's) with ability to identify impacts of potential design changes/applications.
  • Utilizes internal test equipment to assist with validation testing.
  • 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.
  • Effectively reaches out and communicates with sales and field reps when needed.
  • Creates questions/surveys for events to gather input from hospital staff, consultants and field sales reps.
  • Presents to larger internal audiences.
  • Creates new test protocols for more complex experiments. Applies and adapts ASTM standards as needed.
  • Assists in the development and modification of Master Families and worst case considerations.
  • Performs critical CAD print/model reviews for tolerancing and manufacturability and translates outcomes into developing Best Known Methods (BKM's) and associated quality checks.
  • Leads multiple medium to large departmental projects.
  • Works with Quality to define and co-author design risk inputs to Risk Management Report (RMR).
  • Understands Acumed project funding process and provides design/engineering inputs. Evaluates and provides impacts of design changes to ROI with Project Management.


Qualifications:

  •  Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent
  • 3-8 years of related experience required
  • 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.

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