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SOFTWARE ENGINEERING
UP
MECHANICAL ENGINEERING
ID#626
- Senior Project Engineer – Location: Parsippany,
NJ - Salary: $85K to $120K
Relevant Work Experience: 5+ to 7 Years
Unique opportunity for an experienced DEVICE
DESIGN ENGINEER to work with top surgeons and a leading institution on the
development of a breakthrough arthroplasty system. The company is building a
team around an existing concept backed by significant biomechanical research
and an international team of physicians. The current search is for a
technical project leader to design and develop the product.
Candidates must have medical device design
experience (orthopedics, total joints a plus), must be proficient in
SolidWorks and must have excellent design, communication and project
management skills. Candidates must have experience bringing products to
market from concept through transfer and must be experienced and familiar
with manufacturing processes (precision machining, metalworking)
This is a well funded start-up company presenting
the opportunity to work on this top priority project and for career growth in
line with the growth and success of the company.
ID#625 - Senior Engineer, Research
& Development – Location: Irving,
TX – Salary: up to $95K Product - Polymer Implants,
Bioabsorbable Materials
Educational
Requirements
BS degree in Engineering or a relevant scientific
discipline. Advanced degree desired but not required.
Experience
and
Qualifications:
A minimum of five years of experience in the medical
device industry required; or experience in polymer implants. This individual
must possess the ability to be recognized as a technical expert.
SUMMARY
Under general guidance, will perform highly complex engineering duties
associated with the development of new products and materials from initial
concept through production.
ESSENTIAL DUTIES
1. Identify technical opportunities and recommend probes and projects to
management for implementation.
2. Recommend technology improvements for existing processes and products.
3. Direct and manage complex technology development programs that could
involve multiple interfaces internal and external to company.
4. Collect, organize and analyze technical information to support the
development and design of products and processes to manufacture them.
5. Design tooling and develop processes required for the manufacture of
prototypes and final products.
6. Interact with technical, administrative and production personnel at all
levels in the organization, as well as with vendors and suppliers, to develop
documentation and manufacturing procedures for manufacturing processes and
new product designs or modifications or existing products.
7. Develop, manufacture and test prototypes of new design or design
modifications.
8. Confer with vendors and suppliers to arrange for purchase of equipment
material and parts required to carry out development activities or to provide
analytical capabilities in support of developmental activities.
9. Provide support and resources to other departments as necessary.
10. Coordinate the work schedules of technicians working on projects assigned
to the position.
11. Monitor the progress, performance and required training of
technician staff assigned to projects.
12. Other projects as assigned.
SUPERVISORY RESPONSIBILITIES
Function may include supervisory responsibilities for technician level. If
applicable, will offer advice and counsel to the department manager/director
regarding the performance and progress of the technician staff. Responsible
for conducting performance appraisals, and recommending hiring, termination,
disciplining, salary increases to manager/director.
ID#621
- Sr. Engineer – Location: Arizona & Utah – Salary: $90K to $100K
Responsible for all technical aspects
of developing medical devices from concept to market success, including but
not limited to:
- Hands-on involvement with all phases
of medical device development
- Conceptualization and primarily
mechanical design of medical device procedures, instruments, and implants
using fundamental engineering knowledge and principles
- Solid modeling via Solidworks of
design concepts and creation of design drawings using ASME Y14.5, ISO, and
GD&T principles
- Creation of development documentation
consistent with FDA CFR 820.30, such as product specifications, risk
analyses, verification / validation reports, etc.
- Fabrication of prototypes in
conjunction with the internal company’s prototype shop and outside suppliers
- Designing, executing, and analyzing
experiments, verification tests, and validation tests using statistical
techniques
- Transition of new products with
production suppliers
- Travel as needed for development
activities (~10-25%)
Requirements
- Bachelor’s degree in Mechanical or Biomedical
Engineering – Master’s degree preferred
- 2 years experience in design and
engineering capacity – Previous Medical Device experience is preferred.
- Strong mechanical engineering,
design, and analysis skills
- Good verbal and written communication
skills
- Working knowledge of CAD (Solidworks)
and GD&T
ID#620
- Senior R&D Engineer – Location: San
Jose, CA – Salary:
up to $125 – Product: developing less-invasive neurointerventional solutions
to treat cerebral vascular disease,
Hands-on" Sr. R&D Engineer
w/balloon/catheter background
Position Responsibilities
Manage/oversee catheter coating process
Optimize catheter and balloon
properties
Develop new test methods
Implement Design change requests
Design basic fixtures
Write verification and validation
protocols
Position Requirements
5+ years experience in the medical
device industry (preferably cardiology, neurovascular areas). Recent catheter
development and/or balloon experience.
BSME, Biomedical or Chemical
Engineering degree
Familiar with Design Control and GMP
regulations
Ability to write detailed verification
and validation protocols & reports
Proficient in fixture design, and Solid
Works/AutoCAD & modeling
Injection molding, extrusion experience
and familiarity with assembly techniques and composite structures
Excellent communications, both verbal
& written
A venture funded start-up
company developing bio-absorbable drug-eluting stent technologies for
treatment of peripheral vascular disease (PVD). The company is currently located in Mountain View, California,
with a wholly owned subsidiary located in Singapore
Responsibilities
·
Expertise in stent design and all
associated bench evaluations including
design verification tests and documentation
·
Proficient in FEA, CAD Mechanical design
and Solid works
·
Hands on experience with system level
stent-catheter design and process
·
Experience with, biodegradable polymers,
metals and micro machining
·
Solid understanding of product validation
and pre-clinical GLP studies
·
Statistical Process Control (SPC), Design
of Experiments (DOE), Good Manufacturing Practices (GMP), Good Laboratory
Practices (GLP) and ISO.
Medical device regulation and
clinical evaluations
Expertise
and
Personality:
The desired candidate will have experience
with:
·
“Hands-on" approach to product design and problem solving with
the skills required to build a successful team.
·
Be a positive, self-confident, decisive leader who has excellent
communication skills in both oral and written formats, as well as excellent
listening skills.
·
Be known as a person who has high integrity, sound character, a
tremendous work ethic, a good team player, and the passion to succeed.
Education
BS, MS preferred
ID#616 – Senior R&D Engineer – Location: Wilmington, NC
– Salary: up to $100K – Product: Orthopedic/Spine Medical Devices
This position will be responsible for leading product development
from intial concept through product launch as well as ongoing support for
existing product lines. Collaborates
with surgeons and marketing to develop initial design inputs and to optimize
prototypes. Details designs with
manufacturing engineers and vendors for manufacturability and market
introduction. Provides technical
support for product launch and serves as a resource for surgeons and sales
& marketing groups.
Education:
BS in Mechanical Engineering, Biomedical Engineering or
similar discipline with medical device experience (MS a plus)
Experience:
5+ years of medical device development experience
Experience developing orthopedic surgical instruments
and implants
Experience in Project Management including working with
Quality, Regulatory, Manufacturing, Marketing and Suppliers
Skills
Excellent Verbal and Written communication skills
necessary
Ability to work and interface with a range of people and
departments
Computer Experience including Word, Excel, PowerPoint,
Project required.
Effective in conducting mechanical design using 3D CAD
(Solidworks preferred)
Familiarity with ISO quality systems and FDA QSR
Responsibilities
Position will involve all phases of product development
from initial concept through product launch as well as ongoing support for
existing product lines.
Work closely with surgeons to develop initial design
input and optimize prototypes.
Using 3D CAD system to create models for new designs and
product manufacturing prints.
Work with vendors and manufacturing engineers to
optimize designs for manufacturability.
Define validation requirements and required mechanical
testing.
Provide technical support on products for surgeons,
marketing and the sales force.
ID#613 – R&D
Engineer, Implants – Location: Watertown, MA
– Salary: up to $110K plus equity – Product: Biomaterial Platforms
An early-stage medical device company that is bringing
biologically-inspired biomaterials systems to the clinic to improve patient
outcomes. We are a multi-disciplinary team of biologists, chemists, materials
scientists, and engineers, working in close collaboration to understand the
biology of disease and to create solutions that address some of today’s most
challenging and critical unmet clinical needs. To support the development and
implementation of our multi-functional technology platform, the company has
created a state-of-the art research and development environment in the Boston metropolitan
area.
You are
Obsessed with good design
Creative
Able to synthesize input from literature, clinicians,
colleagues, and analysis and testing to define and validate design
requirements
Unafraid of complex design problems that require
multi-disciplinary understanding and coordination
Skilled at prototyping and testing to demonstrate concept
and product feasibility
Comfortable working and communicating effectively in a
cross-functional, highly interdisciplinary environment
Excited about having impact within and beyond your team
Looking to work in an extremely dynamic and fast-paced
environment, and you are prepared to meet aggressive development milestones
Passionate about attacking “the big problems,” and
always seeking new challenges
A highly self-motivated problem-solver
You will be
Working closely with engineers and scientists to develop
novel implantable vascular devices
Documenting your accomplishments in lab notebooks and
design history files per Design Control
Implementing testing capabilities to support device
development
Building consensus across a highly technical, intellectually
challenging organization
Coaching and mentoring across the organization
Your stats
· BS in mechanical, materials, or
biomedical engineering; MS strongly preferred
· You have a track record of novel
design solutions, which may include documentation via patents
· You have several (at least 3)
years of experience in medical device R&D, preferably in an
entrepreneurial environment
· You have knowledge of Design
Control (FDA QSR and ISO guidelines), as well as GMP
· Proficient in 3D CAD, preferably
SolidWorks
You will report to
Vice President, Engineering
ID#614 - Sr.
R&D Engineer, Delivery Systems – Location: Watertown,
MA – Salary: up to $110K plus
equity – Product: Biomaterial Platforms
An early-stage medical device company that is bringing biologically-inspired
biomaterials systems to the clinic to improve patient outcomes. We are a
multi-disciplinary team of biologists, chemists, materials scientists, and
engineers, working in close collaboration to understand the biology of
disease and to create solutions that address some of today’s most challenging
and critical unmet clinical needs. To support the development and
implementation of our multi-functional technology platform, The company has
created a state-of-the art research and development environment in the Boston metropolitan
area.
You are
Obsessed with good design
Skilled at prototyping and testing of interventional
catheter-based delivery systems to prove concept and product feasibility
Able to synthesize input from literature, clinicians,
colleagues, analysis and testing results to define and validate design
requirements
Comfortable working and communicating effectively in a
cross-functional, highly interdisciplinary environment
Excited about having impact within and beyond your team
Looking to work in an extremely dynamic and fast-paced
environment, and you are prepared to meet aggressive development milestones
A highly self-motivated problem-solver
You will be
Driving the development of delivery systems for novel
biomaterials-based vascular implants
Coordinating the efforts of internal and external
resources
Working closely with engineers and scientists to develop
novel implantable vascular devices
Documenting your accomplishments in lab notebooks and
design history files per Design Control
Implementing testing capabilities to support device
development
Building consensus across a highly technical,
intellectually challenging organization
Your stats
· BS in mechanical, plastics, or
biomedical engineering; MS strongly preferred
· You have a track record of novel
design solutions, which may include documentation via patents
· You have a track record of
on-time delivery
· You have several (at least 5)
years of experience medical device R&D, preferably in an entrepreneurial
environment
· You have participated in a
complete development cycle (concept to commercialization)
· You have knowledge of Design
Control (FDA QSR and ISO guidelines), as well as GMP
· Proficient in 3D CAD, preferably
SolidWorks
You will report to
Vice President, Engineering
ID# 603 - Principal R&D Engineer –
Balloon – Location: Menlo Park,
CA – Salary $130K plus, plus
equity
Manage team to design and develop next generation
balloon catheter devices used in treatment of ENT disease.
Manage the design and development of multiple new
dilatation balloon catheter products as well as product changes and
enhancements per design control requirements
Manage vendors and
development partners to meet project requirements and timelines
Supervise assigned engineers
and technicians
Create and maintain project
plans and schedules to complete projects in an aggressive manner
Some hands-on designing and
prototyping of dilatation balloon catheters
Manage development test
protocols, verification reports, and transfer to manufacturing
Contribute to generation and
management of Intellectual Property
Interface with R&D,
Marketing, Regulatory, Quality, Manufacturing, development partners, OEM’s
and physicians
Qualifications:
The successful candidate must
possess:
BSME or BS-BME and 5-10 years
experience working in Class II or Class III medical devices
3-5 years experience working
with balloon catheters or stent delivery systems
Excellent management skills
with at least 2 years experience managing multidisciplinary engineering teams
Excellent track record of
managing complex medical device development from concept phase through design
development, verification, validation, clinical trials, and product release
Strong balloon catheter
design, materials, analytical, and execution skills required.
Experience with high pressure dilatation balloons and balloon catheters
preferred
Demonstrated ability to
communicate concepts, challenges, and project plans to all levels of the
organization
Proficiency in SolidWorks preferred
ID#602
– Principal Engineer - Location: Framingham,
MA - Salary: $90K to $110K plus
equity
A venture backed
startup company. Company has been in
existence for one year and plans to revolutionize how women are treated
for abnormal uterine bleeding (AUB) by developing advanced less-invasive
devices. With over 10 million American
women suffering from AUB.
Company is
well-funded and has established an outstanding Advisory Board of top surgeons
in the Women’s Health Field. An
opportunity to get in at the ground floor and have a huge impact on the
future of the company and the industry.
We are a clinically-oriented, high-tech medical device company looking
for the right person to help grow our business. If you are a medical device engineer with
drive, integrity and a desire to work with a creative and innovative team we
need to hear from you.
Job Summary:
Responsible for designing, documenting,
and verifying new product designs to meet the needs of our customers.
Responsibilities:
· Assume technical leadership role on a
cross-functional team through all stages of product development
· Solicit input from medical thought
leaders, marketing, and other stakeholders to define product specifications
· Develop solutions to design problems
through the application of engineering principals, analysis, and
empirical methods
· Model complex components and
assemblies in CAD and create detailed drawings.
· Build and test prototype designs for
proof of concept
· Develop protocols and perform product
verification and validation testing.
· Compile Design History Files per FDA
requirements
· Perform process-related design tasks
to support pilot manufacturing
· Support production of final product
by troubleshooting manufacturing processes
· Identify suppliers and maintain
relationships to ensure the delivery of superior components and services
· Enhance the intellectual property
position of the company via invention disclosures and patent applications
· Help optimize R&D’s operations
and procedures
Skills and Qualifications:
· BS in Mechanical Engineering or
equivalent, MS preferred
· Minimum 7 years experience in medical
device design with a focus on Class II or Class III devices
· Specific experience with development
of complex electromechanical medical devices is desired
· Hands-on engineering skill with a
proven ability to work well in a team environment
· Strong understanding of engineering
materials, component selection, and design for reliability and
manufacturability
· Proficiency using CAD tools desirable
· Comfortable with all phases of the
product development lifecycle, including design, implementation, debug,
verification, qualification, and transfer
· Excellent oral and written
communication skills
· Demonstrated history of bringing
medical products to market
· Proven track record of creative
problem solving skills
ID#600
- R&D Engineer – Location: Aliso
Viejo, CA Salary: $90K - $125K
Local medical device company focused on
therapeutic vascular devices.
Candidate will report to the Director
of Research and Development.
Primary responsibilities include:
Design vascular devices and contribute
to company's intellectual property portfolio.
Manage new products from conceptual
through manufacturing phases following design control policies.
Conduct animal studies to verify product
performance.
Compose R&D and manufacturing
drawings, using Solid Works design software, to ISO and ANSI standards.
Ensure compliance with FDA and
international regulations.
Support quality system, document
control, and conduct inspections.
Qualifications:
At least five years of R&D and/or
manufacturing technical experience in the medical device industry.
Small company experience, with vascular
device experience preferred.
Bachelor of Science in Mechanical or
Biomedical Engineering or equivalent.
Skills:
Excellent presentation, interpersonal,
communication, follow-though and organizational skills.
Solid works design software experience
is a must.
Ability to write protocols, analyze
data, interpret and write technical reports.
Self motivated with ability to work
independently.
Demonstrated skills in product design
and fixturing development.
Experience specifying and managing sub
contractors/vendors.
ID#599
- R&D Engineer - Location: Mountain
View, CA – Salary –
$60K to $80K
Research & Development Relevant
Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager)
Education Level: Bachelor's Degree
This position will
report to the Research & Development Manager or above.
Responsibilities
include (but not limited to):
*Perform or
coordinate verification and validation activities
*Conduct protocols
(stent and system), test data analysis (including statistical analysis), and
report generation
*Support design
activities
*Coordinate
external testing resources
*Design and maintain
test equipment or lab
*Adhere to timeline
for project, identify resource constraints and requirements
*Continuously
evaluate timeliness of activities and regularly communicates status
*Coordinate
resources within other departments as necessary
*Maintain
laboratory notebook
*Perform design and
failure analysis, reliability studies
*Participate in
competitor analysis
Required qualification/skills:
*Must have 2+ years
successful product development experience in a medical device environment
*Experience in the
design or testing of stents a plus
*AutoCAD or
SolidWorks skills
*Excellent
communication skills, hard worker, and self-starter
*Sense of urgency
and passion
*An ability to get
things accomplished
*Strong
organizational skills
*Degree in
Mechanical or Electrical Engineering or equivalent required
UP
UP
MANUFACTURING ENGINEERING
UP
QUALITY ENGINEERING
UP
ENGINEERING
MANAGEMENT
ID#624 - Senior Project Manager – Location: San Jose, CA
– Salary: compensation to the $150K plus - Surgical and
Percutaneous Valvular Medical Device Company
The Company is emerging with breakthrough technology and has raised
significant venture capital based on its successful development of
proprietary surgical and percutaneous medical devices for the
treatment of valvular heart
disease and congestive heart failure. The
company is
currently developing technologies that enable both cardiovascular surgeons
and interventional cardiologists to customize their treatment of cardiac valve abnormalities, such as mitral regurgitation, based on the
patient’s individual anatomy and physiologic performance. This technology can
be delivered either surgically or percutaneously to treat cardiac valve disease reducing
patient mortality and length of hospital stay.
The position will focus
on taking the company’s surgical technology to a percutaneous technology for
cardiac valve repair, specifically in the mitral valve area. The Senior Project Manager will be responsible
for managing the Company’s contract engineering firm engaged in the
development and manufacture of the surgical product platform. The incumbent
will have control over, and closely manage contract engineers as well as
in-house engineering staff and insure that product development is on time and
on budget.
The candidate we prefer will have ten or more years
of progressively successful experience in a medical device company that
develops cardiac valves via open surgical, minimally invasive surgical or
percutaneous delivery systems. The candidate will have an undergraduate
degree in engineering, mechanical is preferable. An advanced M.S.degree in
mechanical engineering is also highly desirable. Candidates must be able to
manage multiple projects and demonstrate a record of high achievement.
Candidates must possess a strong work ethic along with exemplary interpersonal
skills necessary for communications with contract management employees,
advisors and staff. The candidate must
be skilled in the use of Solid Works, Microsoft Project, and the Microsoft
Office suite of general business applications.
The opportunity is to join an early stage medical device
company with unique technology and a strong IP position as the Senior Project
Manager. The company is financed by a premier venture capital firm and has a
management team that has successfully launched medical device companies. The
SRM will help build the team and infrastructure for the company that will
lead to significant global growth. Attractive compensation, relocation, and
equity that could result in significant net worth.
ID#623 – Project
Manager – Location: Twin Cities,
MN – Salary: up to $120K
Seeking an experienced project manager with demonstrated
ability to manage in-house development and external collaborations. Sample
technology, simulation, laparoscopic, endoscopic, explore new medical device
technology.
Description:
Job Summary: The Division of Engineering and Technical
Services at
Research Hospital,
Twin Cities, MN, designs and develops innovative
systems, devices and instrumentation for the advancement of medical practice,
research and education for
the Research
Hospital.
We are seeking an experienced project manager with
demonstrated ability to manage in-house development and external
collaborations. As a project manager, you will independently manage multiple
medium- to large-scale multi-disciplinary projects from inception to closure
including project definition, scope and requirements development, scheduling,
resource management, risk identification and mitigation, budget and cost
tracking, quality assurance, testing, and change control. You will utilize
established project guidelines, tools, checklists, templates and
methodologies. Scope of projects may include: software (including application
level, firmware, and GUI), hardware (including electrical and mechanical),
various other related sciences (including biology, chemistry, and
physiology), and operational processes.
Qualifications:
Required: BS in Engineering, or a related field with 7
years of related professional experience; with MS or PhD in related fields,
less experience will be considered.
Preferred: PMP certification; experience with group
facilitation, team building and conflict resolution tools and processes to
achieve a motivated and positive team atmosphere; experience managing new
product development projects in a mature development
process environment; experience with Agile development
processes and medical device development is desirable, experience
communicating with customers and senior management; knowledge or experience
with emerging health-care technologies (e.g., simulation, laparoscopic and
endoscopic procedures, imaging); evidence of an ability to learn new
technologies quickly,
to deal with complexity and ambiguity, and to balance
multiple, competing priorities; evidence of an ability to handle challenges
with creativity, flexibility, and humor.
Required / Desired Skills
Skill Required / Desired Amount of
Experience
· MS Project Required
3 Years
· System Development Life Cycle
(SDLC) Highly desired
· Communication Skills (Oral &
Written) Required 7 Years
· Structured Methodology
Highly desired
· PMP Certification Highly
desired 1 Years
· Ability to manage people, budget
and timeline Highly desired 7 Years
· Ability t | 
