Sustaining Engineer R&D Hardware

The R&D Engineer in our Sustaining Engineering department is responsible for providing medical device design engineering support in the sustaining of commercially released medical device products, specifically neuro-technology products utilized at the initial point of care. This is a unique opportunity to work cross-functionally on projects of varying scope across the various stages of the product life cycle.

Purpose Statement

As a Sustaining R&D Engineer, your primary responsibility is design ownership of commercially released products. The design owner uses design control and risk management process along with engineering first principals associated with the design change process to ensure that proposed changes to launched product are systematically and thoroughly analyzed. Additional responsibilities include proposing changes or enhancements to improve overall product design and performance.


Position Overview

  • Located in Bethesda, MD
  • Competitive salary, excellent stock option package and strong benefits


Key Responsibilities

  • The sustaining function has the primary responsibility for protecting the design intent of launched product to meet all safety, efficacy, regulatory, and business performance requirements.
  • Researching, planning, evaluating/testing and drawing conclusions to support recommendations for or against changes that assure design and performance intent are preserved. Typical sources of design evaluations are: improved product safety, quality, and/or regulatory compliance
  • Ensure manufacturing continuity
  • Reduce product cost (operations VIP) through material/design changes
  • Manage the End of Life / Inactivation phase
  • Provides technical and project support for portfolio expansion (line extension) or sustaining-focused projects.
  • Develops and controls prototypes throughout testing, analysis, design refinement and associated documentation.
  • Evaluates and develops engineering drawings, conducts tolerance analysis.
  • Participates in the remediation of product Design History Files to ensure compliance to standards.
  • Learns/understands clinical application of products to aid in failure investigation for fielded and returned products.


Postion Requirements

  • Bachelor's or Master's Degree in Electrical Engineering or equivalent required
  • Minimum 5-7 years of experience in the development of medical devices including experience in sustaining or manufacturing engineering
  • Design control/Design Change process experience
  • Experience with manufacturing and assembly of electro-mechanical devices
  • Strong statistical analysis and data analysis skills and experience
  • Knowledgeable of full life-cycle product development from concept to manufacturing.  Comfortable dealing with vendors and contract manufacturers for prototype to production builds
  • Capable of generating drawings for testing and manufacturing using a variety of CAD packages
  • Hands on ECAD experience with schematic capture and PCB Layout tools. Capable of generating drawings and notes needed for board fabrication and assembly
  • Some travel to contract manufacturer to support production build may be required
  • Design, development, and troubleshooting of embedded computer systems, data acquisition platforms, digital systems and circuits; PCB layout experience a plus
  • Familiarity with one or more of the following desired: DSP, FPGA, CPLD, MCU, Op-amps, Tl DaVinci microprocessors, power management and battery charging
  • Strong technical leadership skills with a track record of identifying, evaluating and solving complex technical problems
  • Ability to communicate in a clear and concise manner, whether verbally or in writing
  • Operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development.
  • Comfortable working in a fast-paced start up environment

Preferred Qualifications

  • Strong problem solving skills
  • A track record of accomplishment and innovation in driving multiple manufacturing programs or processes
  • Ability to analyze and implement mix signal analog and digital board design; strong hardware debugging skills are a plus
  • Experience working on cross-functional, cross-site, and cross-cultural teams
  • Ability to manage multiple tasks/projects
  • Familiarity with the failure analysis process and experience utilizing systematic tools such as Is / Is not and Fishbone
  • Knowledge of material biocompatibility (and associated properties) for medical devices
  • Documentation management
  • Working knowledge and familiarity with the IS0-14971 Risk management process
  • US and International Regulatory Standards Requirements
  • Strong communication skills with experience communicating to several layers of management
  • A track record of accomplishment and innovation in driving multiple manufacturing programs or processes

Quality System Requirements

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.



Qualified applicants are encouraged to send their resume and a cover letter including availability to 


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