Job Description:
Electronics Engineering Manager
MedQuest is seeking an
Electronics Engineering Manager who is an experienced innovator in medical
electronic product development through release to market. We are seeking a
‘hands on’ leader who enjoys and excels in a fast paced and innovative
environment.
This person will be a
key member of the development team.
This
person will be responsible for development of
analog & digital electronic systems for use with an implantable artificial
blood pump (LVAD) for human use. This includes the electronic circuitry as well
as the entire device including packaging, human factors and interface, testing
lab certifications, establishing manufacturing, validation testing and
documentation.
[GB1]
DUTIES AND RESPONSIBILITIES (INCLUDE PERFORMING AND MANAGING):
-
Manage
research, specification, development, testing, and certification of complete
medical electronic products.
-
Develop
and maintain project plans, schedules, budgets and accountability. Lead regular team meetings to coordinate
development work. Directly responsible
for executing project plans on schedule and within budget.
-
Responsible
for hiring, personnel development plans and performance reviews.
-
Work
with other staff to ensure reliability of the product. Participate in and/or lead effort in fault
tree analysis (FTA) and failure modes and effects analysis (FMEA). Participate in development of accurate
reliability predictions for the electronic hardware and packaging system.
-
Validation testing
including outside laboratory (EMI/RFI, safety, etc.) certifications.
-
Transfer from
development into manufacturing including creation of documentation for systems
such as Bills of Material, sources of supply for components, etc.
-
Development
and documentation of product and mfg. processes.
-
Supports
cross-functional teams in the development of highly reliable, safe, producible
products.
-
Must
have experience in conceiving, designing, building, testing, troubleshooting,
and modifying electronic systems.
-
Willing to perform and oversee
performance of a variety of assignments such as:
o Getting circuits & system prototypes fabricated.
o Finding vendors & sources for components, PCB’s
& testing.
o Working with vendors to get prototypes and parts
built.
o Writing and executing test protocols.
o Documentation of components and circuits.
o Whatever is needed to get the job done.[GB2]
ESSENTIAL
QUALIFICATIONS, SKILLS & EXPERIENCE:
-
Experience
in bringing medical electronic equipment (FDA Class III preferred) from concept
through development, testing, manufacture and release to market.
- Design and analysis of reliability critical electronics and software systems.
-
Technical
leadership skills with the ability to devise innovative solutions to technical
problems.
-
Experienced
with instrumentation electronics, signal conditioning, digital and analog
hardware development. development, including
sensors, and related hardware such as connecters and feedthroughs
-
Project
and people management skills.
-
Hands
on engineering and problem solving in the areas of:
o
Invention/creation/innovation.
o
Circuit
development and design.
o
Prototype
development and testing.
o
Hands
on testing, troubleshooting, and problem resolution.
o
Documentation
& specifications for components, circuitry, packaging, testing, etc.
o
Development
of a complete product including packaging, human factors, etc.
o
Reliability
testing and screening.
o
Preparation
for manufacture including test methods and fixtures.
o
Manufacturing
and end customer support.
-
Excellent
written and verbal communication skills.
-
Design for low leakage
current and other patient safety characteristics.
-
Laboratory
certification testing of the final product (EMI/RFI, electrical safety,
environmental, etc. to UL, CSA, IEC and other medical and safety standards).
-
Design controls, documentation
and organization in an FDA regulated environment
- ISO-9001 or ISO-13485 certified product development and manufacturing environment.
DESIRABLE
SKILLS & EXPERIENCE:
-
DSP
based digital electronics systems.
-
Sensors, especially inductive
(eddy current) or other non-contact position sensors.
-
DSP based digital
electronics systems.
-
Instrumentation
and sensor signal conditioning electronics.
-
Noise
suppression and grounding techniques.
-
EMI
/ RFI immune design and problem solving.
-
Closed
loop (servo) position control systems (analog &/or digital).
-
User
interface development for electronics products
-
Background
in hybrid microelectronicselectronics
miniaturization, including high-reliability hybrid microelectronics, is a
plus.
-
Semiconductor strain
gage experience is a plus.
-
Battery charging and
system power management.
ATTRIBUTES:
-
[GB3]Able to develop system architecture and approaches.
-
Able to efficiently
develop practical, reliable, effective designs.
-
Able to quickly discover &
implement the simplest, most direct answers & solutions to challenging
problems.
-
Proficient
at conceiving, designing, building, testing, troubleshooting, and modifying
electronic systems.
-
Excellent problem solving
skills.
-
Able to create and efficiently
execute a plan.
-
A good project finisher.
-
Excellent verbal and written
communication skills.
-
Creative / Flexible /
Adaptable / Efficient.
-
Get along well with a team.
-
Self directed.
-
Self-motivated.directed and
self-motivated; able to contribute independently.
-
Anxious to learn new skills.
-
Able to have fun and enjoy the
work.
-
Able
to contribute independently.
-
Embraces creativity and
innovation.
EDUCATION/EXPERIENCE:
Electronics Engineering or similar degree, plus ten (10) years experience in
medical electronic instrument design and product development, including management
experience.