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Location:
US-UT-Salt Lake City
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Job Type:
Full Time
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Industry:
ManufacturingWholesaling/Consumer
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Job Function:
Engineering/Other
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Compensation Profile:
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Salary Range:
60000-70000 year
Description:
Plan, design and coordinate the development and implementation of manufacturing
processes and related quality/engineering activities in any of the plants
to support new product development as well as existing production. Provide
process development support to new product development and technology teams.
Comply with all local quality policies, procedures and practices through
consistent application of sound quality assurance principles.
Requirements:
REQUIREMENTS: B.S. Degree in mechanical, manufacturing or electrical engineering
or a related science field and training in design of experiments and statistics.
Six (6) years of experience in various engineering fields relating to manufacturing,
quality control, equipment design and process development. Candidates with
prior medical device experience are preferred.
Other:
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Education:
4 Year Degree
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Experience:
5+ Years
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Travel: 0%
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Quality
Engineering Various Positions
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Location:
US- San Jose Bay Area (No Relocation!)
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Job Type:
Full Time
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Industry:
Medical Device
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Job Function:
Engineering/Other
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Compensation Profile:
-
Salary Range:
90,000-125,000 year
Typical duties
Responsible for Controlled Environment Room monitoring and re-qualification
Managing Quarterly Sterilization (Gamma and E-beam) Dose Audit
Responsible for process and equipment qualifications (e.g. IQ, OQ,
PQ) and GR&R
Responsible for implementing supplier Certification program by measuring
supplier performance, delivery, pricing, and overall service and communication.
Manufacturing tooling & fixture design
Providing new product development support to R&D. Perform FMEA,
CE
Essential requirement verification, hazard analysis, tooling/fixture
validation
Participating in design reviews at appropriate phases.
Coordinated Compliance Testing efforts with regards to EN 60601-1-2,
IEC 60601-1, IEC 60601-2-220 in order to obtain CE and ETL markings.
Develop and implemented Quality System to ISO 9001:1994 and GMP compliance
per QSR
Team member during PMA audit and close-out of 483s
Develop and implemented ESD control program, Inspection processes
SPC tracking of incoming inspection, in-process inspection, CAPA, Final
Test
Other:
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Education:
4 Year Engineering Degree Required
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Experience:
5+ Years
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Travel: 0%
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Regulatory
Specialist
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Location:
US-UT-Salt Lake City
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Job Type:
Full Time
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Industry:
Medical Device
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Job Function:
Regulatory
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Compensation Profile:
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Salary Range:
$60,000-$87,000 year
On assignment, implements or oversees the preparation of Investigational
Device Exemption (IDE) protocols between the company's Medical Affairs
office and product teams, writes IDE and aids with its implementation.
May work with contract research organizations to develop and implement
clinical trial protocols. Serves as RA representative on product teams
as assigned and signs test protocols and reports as required. Develops
and administers new product field trials as required. Coordinates the collection
of data and information for regulatory submissions; writes the required
regulatory submissions for new company's products. Performs GMP/ISO 9000
audits as requested by Department Head. Performs ECN review and sign-off
for any “special orders” for compliance with FDA custom device policies
as well as update RA database of special orders. Performs special projects,
such as administering recalls, as required by Department Head. Provides
RA with FDA device listing/registration information As requested, serves
as alternate FDA inspection coordinator. Prepares and submits PMA annual
report and signs-off PMA related ECNs. Serves as the
company's international information contact person, coordinates the preparation
of international dossiers with the assigned product teams and updates them
as required. Develops and maintain MD. and vigilance reporting sytem.
Requirements: Minimum of 1 year clinical experience. Bachelors Degree
in a life, law or engineering science field. Five or more years experience
in regulatory affairs with Class II or III medical devices. Exposure to
IDE’s and PMA’s
Other:
-
Education:
4 Year Degree Required
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Experience:
5+ Years
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Travel: 10%
National Sales Training Manager
POSITION SUMMARY
Under the direction of the Vice President of Sales, designs and implements
the Sales Training Program for newly hired and current field sales employees,
marketing professionals, and other technical support employees. Ensures
that the sales training strategy and goals are aligned with those of the
division.
MINIMUM QUALIFICATIONS
This position requires a minimum of a Bachelor's Degree; an advanced
degree in Business Management or Education is preferred. This position
also requires a minimum of five years’ of sales experience, five years’
of training development, design and implementation experience, and demonstrated
human relation and communication skills.
The incumbent must demonstrate the potential ability to perform the
essential functions of the job as outlined in the duties and responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The following duties and responsibilities are intended to be representative
of the work performed by the incumbent(s) in this position and are not
all-inclusive. The omission of a specific duty or responsibility will not
preclude it from the position.
1. Conducts training needs analysis to determine knowledge and skill
requirements for new sales hires, and sales employees at various stages
in their careers.
2. Develops the sales training process to ensure new hires are capable
of applying selling skills and product knowledge as soon as possible in
the field, and current sales employees have the knowledge and skills to
sell new products and effectively use territory management tools.
This may include pre-training for new hires, formal classroom training,
field training, on-line applications for new product launches, and intermediate
sales training for experienced sales employees.
3. Designs competency-based training objectives with measurable objectives.
4. Develops agendas for sales training at National Sales Meetings, District
Meetings, and any training events held during conventions. Reviews
Product Manager lesson plans to ensure state-of-the-art training technologies
are being used.
5. Develops and implements product training materials. Creates
and distributes sales training manuals and supplements. Works closely with
Marketing to ensure complete understanding of new product features for
integration in sales training material.
6. Manages the Field Sales Trainers. Defines criteria for selection
and prepares a slate of candidates for review by the Sales Management Team.
Ensures that Field Sales Trainers have the knowledge and skills required
for formal classroom and field instruction. Develops lesson plans
for in-house training, and guidelines for field training including evaluation
methods. Schedules Field Trainers for formal classroom and field
training.
7. Works with the Territory Managers in the field as requested.
8. Develops, implements and tracks sales contests.
KNOWLEDGE AND SKILLS
1. Knowledge of competitive products.
2. Knowledge of adult learning theory, needs analysis, curriculum design,
training evaluation, and advanced training techniques.
3. Knowledge of models of selling skills, and management tools for enhancing
sales force productivity.
4. Knowledge of basic anatomy, including medical terminology and surgical
procedures related to the placement of companies products.
5. Excellent listening and communication skills.
6. Company policies and procedures related to the sale of the companies
products.
7. Knowledge of contract administration.
ORGANIZATIONAL RELATIONSHIP
This position reports to Vice President of Sales who in turn reports
to the President.
PRINCIPLE CHALLENGES AND PROBLEM SOLVING
Manage the variety of different projects that are continually ongoing,
and ensure that they are completed in a timely manner. Effective
participation in sales training planning, marketing strategies and product
development to ensure the companies continued growth. Effective management
of the Sales Trainers to enhance the training program.
Sr. Financial Analyst
or Manager
Reynosa, Mexico ---Can live in McAllen Texas
POSITION SUMMARY: This individual will work closely with the Plant Controller
and departmental managers to drive optimal financial performance for the
company by identifying opportunities and implementing changes in process
controls. This individual will be responsible for reporting on inventory
transactions, inventory balances, and inventory reserves. This individual
will also be the leader of cost saving projects; identifying, tracking
and reporting on cost saving initiatives. In addition, this individual
will heavily participate in the preparation of the annual Business Plan,
year-end Reporting and projects as assigned by the Plant Controller. This
individual must be competent at managing several projects simultaneously
with short deadlines.
MINIMUM QUALIFICATIONS: This position requires a minimum of a Bachelor
Degree in Accounting or related area, 4 years experience with 1 year of
cost accounting in a manufacturing environment. MBA and/or CPA/CMA preferred.
This position also requires demonstrated knowledge of personal computers,
spreadsheets, relational databases, and word processing software. The individual
must demonstrate the potential ability to perform the essential functions
of the job as outlined in the duties and responsibilities.
KNOWLEDGE AND SKILLS: 1) Understanding of financial reporting and the
required statements and supporting ledgers. 2) Understanding of generally
accepted accounting principles and cost accounting, particularly in a manufacturing
environment. 3) Working knowledge of inventory control procedures. 4) Proficient
in the use of PCs and computers and spreadsheets and relational databases.
5) Strong analytical skills.
ORGANIZATIONAL RELATIONSHIP: This individual reports to the Plant Controller
who reports to the Vice President and Controller / Division.
ESSENTIAL DUTIES AND RESPONSIBILITIES: The following duties and responsibilities
are intended to be representative of the work performed by the incumbent(s)
in this position and are not all-inclusive. The omission of a specific
duty or responsibility will not preclude it from the position. 1) May supervise
other accounting personnel. 2) Assist in preparation of monthly, quarterly,
and annual financial statements and related management reports and the
annual Business Plan, including profitability of product lines. 3) Complete
monthly closing activity related to inventory, inventory reserve, spending
and related management reports. 4) Develop annual Cost Standards. 5) Participate
in semi-annual physical inventory. 6) Initiate, manage, and track cost
improvement projects for the Company. 7) Develop and monitor the necessary
MIS systems to support the Division's cost, inventory and financial needs.
8) Participate in special projects assigned by the Plant Controller.
PRINCIPAL CHALLENGES AND PROBLEM SOLVING: This position has the challenge
of independently analyzing and presenting, for review by financial management,
monthly financial performance, issues, trends and potential corrective
actions. In addition, strong analytical and knowledge of financial interrelationships
will be called on to be an effective analyst.
Senior Technology Engineer
POSITION SUMMARY: This position is responsible for coordinating and
testing of long term technologies with internal and external laboratory
services; assisting in the development of technology processes and coordination
of technology transfer from different manufacturing sites; coordinating
and conducting materials analytical evaluations.
MINIMUM QUALIFICATIONS: This position requires: 1. a Bachelor degree
in science or engineering with 6 (six) years of engineering experience
within the medical device or equivalent industry, OR 2. Masters degree
with 5 (five) years of engineering experience within the medical device
or equivalent industry. The above experience must include effective project
management skills in both corporate and research settings. Academic background
should include biological and/or microbiological science, materials/biomedical/chemical
engineering and/or chemical/biochemical studies.
The incumbent must demonstrate the ability to perform the essential
functions of the job as outlined in the duties and responsibilities. Must
also understand and follow company procedures and regulatory requirements.
KNOWLEDGE AND SKILLS: 1. Ability to make and present engineering decisions,
2. Strong interpersonal skills, 3. Specific specialized engineering skills
such as: a) Basic tooling design and drafting knowledge, b) Analyze and
optimize existing process and ability to create new processes, c) Create,
analyze and optimize manufacturing and quality systems, d) Basic product,
design and prototyping, e) Material Science (polymer biomaterials, polymer
and material analysis methods, gas plasma or corona, discharge technologies),
f) Bioengineering principles. 4. Comparative statistics. 5. FTIR, GC-MS,
CLM, XPS, Contact angle, AFM, SEM-EDS. 6. Software application skills.
7. Problem solving ability. 8. Ability to create, review and coordinate
test protocols and reports. 9. Oral and written presentation skills. 10.
Comprehensive understanding of regulatory environment. 11. Demonstrated
ability to create and execute multi-project plans.
ORGANIZATIONAL RELATIONSHIP: This position reports to a Staff Engineer,
Manager or Director in the Applied Research and Technology Group. This
position may supervise technicians and other engineers.
ESSENTIAL DUTIES AND RESPONSIBILITIES: The following duties and responsibilities
are intended to be representative of the work performed by the incumbent(s)
in this position and are not all-inclusive. The omission of a specific
duty or responsibility will not preclude it from the position.
Scope:
1. Develops Innovative ideas for the organization.
2. Broad business and technical understanding.
3. Coach/Mentor.
4. Influences Others across organization.
5. Results Oriented.
6. Critical Decision Maker in areas of engineering and business needs.
7 Project Leader.
8 Networking savvy.
Potential Task Assignments within the scope of this position:
1. Initiates new or revised documentation and tracks through
appropriate approval cycles and implementation.
2. Maintains a professional working relationship with internal and
external customer and support staff.
3. Provides technical support on components, material methods, systems
and equipment.
4. Develops physical and functional test requirements to assure specifications
and regulations are met.
5. Writes and approves protocols, reports and data.
6. Manages and performs testing outlined in protocols and test methods.
7. Manages project planning, scheduling and tracking.
8. Plans and coordinates engineering test builds.
9. Prepares and presents oral and written project updates and technical
discussions.
10. Develops and implements procedures/policy.
Research and Development Focus: Responsible for concept generation,
design, development and evaluation of new products, materials and technologies.
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Medical
Device Jobs and Recruiting
