Description

The Senior Product Development Engineer plays a key role in the development, support, commercialization, and improvement of a complex electromechanical, radiation therapy medical device.  Major objectives are to support the design, prototyping, and testing of product improvements, support the maintenance of Research & Development (R&D) devices, and to facilitate design transfer of R&D device improvements to manufacturing.  This role requires demonstrated technical competence in systems engineering, system integration, and hands-on system problem solving, technical depth in mechanical or electrical engineering, and very effective communication and interpersonal skills.  This role will serve as a primary engineering liaison between R&D and New Product Introduction (NPI) and will be an evolving position in a start-up company environment.

Responsibilities

  • Gain systems-engineering level knowledge of highly-complex medical device.
  • Execute R&D device activities including regular health checks, maintenance, troubleshooting and repair, system calibrations, Software/Hardware upgrades, revision control, testing, debugging and data analysis of measurement performance.
  • Keep performance and maintenance records on the equipment.  Maintain physical configuration reports, and plan maintenance and upgrade paths.
  • Complete initial diagnosis of any system issue, drive to uncover root cause, and devise or drive a team to define solutions for complex problems. Support the detailed analysis and tradeoffs for the various solutions, develop plan of action, and effectively communicate plan to colleagues.
  • Support subsystem builds, full system builds, and system integration during product improvement developments, including hands-on assembly.
  • Troubleshoot component/system failures during assembly and as part of corrective action investigations.
  • Help create and execute test plans for complex subsystems. This will involve integration of subsystems, testing against design tolerances and specifications, analyzing test data, and generation of reports.
  • Partner with R&D engineers to develop the assembly and test manufacturing documentation (Manufacturing Process Instructions (MPIs), travelers, Bill of Materials (BOM)) for product improvements and partner with NPI to transfer into routine manufacturing.
  • Other duties as assigned.

Requirements

  • Minimum of 5 years’ direct experience as a R&D/Manufacturing Engineer in a relevant environment (medical device and/or capital equipment).
  • Bachelor of Science degree in mechanical, electrical, systems Engineering, Physics, or similar discipline.
  • Experienced with integrating and troubleshooting complex electromechanical systems and related software.
  • Demonstrated experience with all phases of product development including design, bring-up, debug, and transition to manufacturing.
  • Able to isolate and debug hardware and software problems in complex systems.
  • Demonstrated competency and understanding of system electronics.
  • Expertise with electrical test equipment including logic analyzers, oscilloscopes, and digital multi-meters.
  • Strong attention to detail and organizational skills.
  • Strong communication and documentation skills.
  • Ability to be proactive and collaborative in a dynamic start-up environment.
  • Experience with radiation therapy beam systems highly desirable.
  • Some domestic travel may be required.

 

 

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at RefleXion Medical are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.