Acumed
  • 28-Jun-2019 (PST)
  • Sustaining Engineering
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

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


About Us

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.

Senior Product Engineer, Sustaining

The Senior 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

  • Additional duties which require little supervision to prioritize and manage multiple tasks and deliverables and resolve potential roadblocks.
  • 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 5 yrs. experience preferred.
  • Demonstrate proficient and independent management of junior level staff, multiple vendors and ability of building relationships with Surgeons and Sales force.
  • Demonstrated ability to lead and manage teams, project schedules and meet project milestones and deadlines.
  • Ability to Develop design solutions for complex and larger scale problems, under minimal supervision.
  • Ability to lead effective brainstorming and troubleshooting sessions and drive root cause analysis teams.
  • Proficient in creating test protocols and correlating methods to clinical relevance when applicable.
  • Proficient at applying design for manufacturing (DFM) principles to designs.
  • Proficient at 3D Tolerance stack analysis preferred.
  • Knowledgeable of 510(k) process and CE marking processes and requirements.
  • Ability to apply advanced FEA principles and tools for more complex risk mitigation preferred.
  • Proficient with one or more products (and associated anatomy) and able to support Product Management and Sales events.
  • Ability to co-author Risk Management documents with quality, including severity and probabilities of occurrence.
  • Knowledgeable of Acumed's AFE/ROI process and ability to discern impacts to risk by design changes.
  • Ability to apply more complex statistical tools to analysis and interpret results.
  • Proficient in at least 1 technical specialty area and Knowledgeable in a second preferred.
  • Ability to conduct research and apply clinical outcome/data to IOVV criteria and user need inputs.

 

Acumed and ACUTE are equal opportunity employers. 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.

Acumed
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share This Page
  • Facebook Twitter LinkedIn Email
.
Logo Solutions Resources Company Events & Education Press Login Home