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A Technical Recruiting Organization Serving Medical Product Companies |
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Available Opportunities |
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Search our list of currently available jobs in General Engineer Management and Supervision, Packaging Engineering, Mechanical Product Design Management, Software Engineering, Manufacturing, or Scientific Areas. NO SALES POSITIONS . ID#662 -
Mechanical Engineer (MEDICAL DEVICE EXPERIENCE REQUIRED)- Location:
Medical Device Startup Position responsibilities include: · overall product concepts, · design, development, analysis and testing for an intravascular implantable system and associated catheter tools used in the implant and explant of the device. Specific duties include: · analyze catheter and related mechanical designs and design requirements · solid modeling of design systems and subassemblies ·
design, document, and set-up experiments,
manage evaluation testing in the laboratory environment. Requirements
Qualified candidates must possess the following: · BS Degree in Mechanical or Plastics Engineering · 3 years experience in medical devices · experience in 3D solid modeling required · experience with catheters, stents, stent delivery systems, surgical tools, vascular introducers, vena cava filters or associated products is required. ID#661 - Project
Engineer - Location:
Educational Requirements – Candidate will have BSME
(MSME preferred). ID#660 - Senior
Engineer Process & Product Development - Location: Manages
a wide variety of technical tasks and projects involving the development of
new products and manufacturing processes. Duties
& Responsibilities: · Contribute directly to the development
of new product concepts, processes, and techniques to ensure that products
meet customer’s needs and are high quality and low product. · Serve as a technical interface within
company between the Manufacturing and Materials, R&D, Quality,
Regulatory, and Marketing organizations. Specific
responsibilities include: · Manage/hands-on design and development
of new products and processes as well as product changes and enhancements. · Perform hands-on design and prototyping
of BALLON CATHETERS and other related products. · Work closely with external partners in
the development of new technologies and devices · Plan, schedule and complete projects in
an aggressive manner. · Write test protocols and reports for
design verification/process validation, complete testing, and transfer to
manufacturing. · Contribute in generation of intellectual
property and assist in management of companies IP. · Supervise assigned engineers,
technicians and assemblers. Qualifications: · Bachelor's degree in Mechanical
Engineering or related discipline. · Minimum of five (5) years of
demonstrated leadership in a medical device environment with HIGH-PRESSURE
BALLOON CATHETER EXPERIENCE. · Ability to manage resources: time,
budget, and people. Strong people management skills is essential. · Knowledge of and compliance with
applicable Quality System requirements (e.g., QSRs, ISO & MDD). · Strong written and verbal communication
skills to communicate effectively at all levels. · Good presentation skills to deliver
speeches and/or presentations effectively to a variety of audiences. · Hands-on experiences with SolidWorks or
ProEngineering modeling software. · Proven application of statistics to
decipher process validation, process control and design verification testing
data. · Proven practice of process validation,
including use of Design of Experiments (DOE) for process scoping. · Medical Device mechanical or electrical
engineer with proven product design and problem solving capability. · Catheter development and manufacturing
experience are a plus · Highly motivated individual who works well with all company functions and has a proven track record on leading projects to completion, on-time and within budget ID#658 - Research
and Product Development Engineer – Location: Medical catheter manufacturer located in the Responsible for the design, development, documentation,
testing, release, and manufacturing support from concept to obsolescence, of
finished medical devices. Ensure medical devices are designed, developed,
documented, tested, and released according to applicable FDA, ISO, EN, and
other international standards, regulations, and company procedures. Qualified candidates will possess the following: * B.S. degree in mechanical engineering, * At least two years of product development experience
in the medical device industry * Hands-on technical problem solving ability * Strong desire to both contribute and learn in a
cross-functional team environment * First-rate 3D-modeling skills, * Excellent verbal and written communications
skills ID#657 – Principal
Engineer PTCA Balloon Catheter – Location: Company offers a wide variety of interventional devices for
use in treatment and diagnoses of heart and abdominal diseases. By conducting
extensive joint R&D activities with physicians to determine new
requirements in medical treatment, we are able to implement products based on
completely new ideas to improve the QOL (Quality Of Life) of patients. Responsibilities Requirements - B.S. in Mechanical Engineering, or equivalent. ID#616 – Senior
R&D Engineer – Location: Publically held Company, developing minimally invasive
surgical instruments. 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: o BS in Mechanical Engineering,
Biomedical Engineering or similar discipline with medical device experience
(MS a plus) Required Experience:
o 5+ years of medical device
development experience o EXPERIENCE
DEVELOPING ORTHOPEDIC SURGICAL INSTRUMENTS AND IMPLANTS o Experience in Project Management
including working with Quality, Regulatory, Manufacturing, Marketing and
Suppliers Experience with
surgeons and animal testing Skills o Computer Experience including
Word, Excel, PowerPoint, Project required. o Effective in conducting mechanical
design using 3D CAD (Solidworks preferred) o Familiarity with ISO quality
systems and FDA QSR Responsibilities o Position will involve all phases
of product development from initial concept through product launch as well as
ongoing support for existing product lines. o Work closely with surgeons to
develop initial design input and optimize prototypes. o Using 3D CAD system to create
models for new designs and product manufacturing prints. o Work with vendors and
manufacturing engineers to optimize designs for manufacturability. o Define validation requirements
and required mechanical testing. o Provide technical support on
products for surgeons, marketing and the sales force. ID#656 - Senior
Principal Mechanical Engineer - Location: Develops breakthrough medical
devices for respiratory support. Seek
a Senior or Principal Mechanical Engineer to join there Research and
Development team and participate in the design, pre-clinical, and clinical
testing of there advanced respiratory support devices. You will be reporting
to the VP R&D. Responsibilities include: Lead mechanical engineering
efforts (design and analysis) for the development of oxygenators and
accessories (includes subassemblies, catheter) Provide guidance and support the
development of the electromechanical driver Develop Verification and
Validation protocols and follow through their completion Participate in establishing the
supply chain and manage suppliers as necessary Develop documentation as
required by the company’s QSR Skills/Requirements: BS or advanced degree
(preferred) in mechanical engineering. 5+ years product development
experience (medical device industry preferred). Hands-on mechanical and
electro-mechanical design experience of rotating mechanisms, pumps, polymeric
and elastomeric components, and catheters. Experience in systems level
design and analysis. Preferably possess CAD design
skills (Solidworks). Working knowledge of geometric
dimensioning and tolerancing. Must be able to communicate
ideas and information clearly, effectively, and frequently (oral and/or
written) within program team and throughout the company Background in fluid mechanics is
preferred Possess a strong working
knowledge of FDA's Quality System Regulation (QSR) and practical application
through design control, SOP's, verification, and validation testing Familiarity with medical device
standards and CE mark requirements for international use (including
Shock/Vibration, Shipping/Transport, and Environmental requirements) Experience interfacing with
external firms and suppliers (design and contract manufacturers) ID#655 - Principal
Engineer - Location: MEDICAL DEVICE EXPERIENCE REQUIRED Very early stage startup, experienced successful
founders. Solutions for today’s dental implant market. As part of this vision
the product development group is driven to ensure that they stay on the
cutting edge of implant technology. Experience with ISO requirements and GMP guidelines, FDA
regulations and medical device design control is required ID#649 - Sr.
Product Development Engineer/Team Leader – Location: Partner with physicians, inventors, and corporations to
develop medical devices ORTHOPEDIC that improve the standard of patient care.
From initial concept to a medical device ready for clinical use Our state of the art facility provides the most advanced
tools to support design, prototyping, biomechanical and pre-clinical testing.
This growth-oriented Product Development Engineer position will be
responsible for all technical aspects of developing medical devices from
concept to market success, including Supervision of Jr Engineer Strong, 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 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 5+ years experience in design and engineering capacity –
Previous Medical Device experience Strong mechanical engineering, design, and analysis
skills Good verbal and written communication skills Working knowledge of CAD (Solidworks) and GD&T Company offers a competitive total compensation
package including medical, dental and vision, 401-k with employer match and
immediate vesting, and an annual incentive bonus program plus relocation. ID#647
– Senior Design Engineer – Location: This individual will be responsible for bringing a
product from concept through design to production. The Senior Design Engineer
will interface with cross-functional teams, clinical advisors and vendors for
evaluation of new products as well as address design issues/ maintenance of
existing ones. This position will take product/process concepts and prepare
layouts, tolerance analysis, models and detailing of flexible instruments
utilizing Solid Works. Successful candidates must have the ability to
multi-task and work effectively under deadlines and timeframes. Experience
working in the medical device manufacturing industry is required. ID#626
- Senior Project Engineer – Location: 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. MUST HAVE MEDICAL
DEVICE INDUSTRY EXPERIENCE ID#664 - Quality Engineer -
Location:
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