|
|
|
|
|
|
|
|
|
|
|
|
|
Diversity is the most universal human quality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Job Name
|
Description
|
|
Dir. Of Quality and
Regulatory Affairs
|
SUMMARY:
Responsible for the Quality and Regulatory requirements as it pertains to
medical
device products designed, developed and manufactured by the company.
DUTIES:
1.Performs as management representative responsible for ensuring quality
systems requirements are established and maintained.
2.Reports performance of quality systems to
executive management.
3.Plans, develops regulatory approval strategies
and final approval of regulatory submissions.
4.Overall responsibities
for regulatory vigilance: MDV, MDR, complaints, and
Recalls
5.Assign follow up on FDA requests for more information.
6.Provide regulatory guidance on engineering
changes affecting Submissions to FDA other regulatory impact.
7.Initiate and follow up on external audits and
to assure continued compliance.
8.Assist in rollout / development of Integrated
Management System (IMS).
9.Approve promotional and technical literature
for regulatory compliance.
10.Responsible for all Safety Related Customer
Notifications and Product Recalls.
11.Participate and represent QA and RA in
Product Steering Groups (PSGs)..
12.Assist in legal/litigations matters.
13.Acquire and maintain knowledge for DMSI
spectrum of regulations.
14.Integration of the tasks for the management
representative of the IMS Manual, in addition to the other tasks re:
Quality Management System (QMS) etc.
•Ensures that processes needed for
the IMS are established, implemented, and maintained
•Reports to the top management on the performance of the IMS and
any need for improvement
•Ensures the promotion of awareness of customer requirements
throughout the organization
•Establishes and updates objectives and rules for implementation of
a uniform IMS within the legal entity
•Conducts quality audits to monitor compliance with the objectives
and rules of the IMS
•Manages and complies quality reports to illustrate and evaluate
compliance with the IMS
•Manages and transfers global process descriptions, standards,
internal and external regulations in the legal entity
•Conducts Management Reviews per established procedures
15. Responsible for implementing appropriate part of
Process House.
16.Perform other duties as required.
EDUCATION:
Bachelor or Science
EXPERIENCE:
10+ years experience in Quality Assurance Environment. Knowledge of
Quality and Regulatory Standards such as ISO 9000, ISO 13485 required, MDD, as well as other applicable product
standards requirements.
|
|
Composites Engineer
|
This
hands-on position focuses on designing and fabricating innovative composite
product designs and processes, as well as material selection and
recommendation. The successful candidate will participate in the
development, management, and successful completion of government and
industry development programs involving composite materials technologies
in such areas as shipbuilding, aerospace and space applications.
Requirements:
- BS in Materials, Mechanical or
Aerospace Engineering; MS is a plus.
- 5+ years of industry experience in
the design and manufacture of composite structures.
- Technical and hands-on
experience with VARTM and related tooling design.
- Demonstrated ability to develop
composite product designs, and verify those designs through
prototype fabrication and testing.
- Ability to handle multiple
projects and follow through to completion.
- Proficiency in CAD tools and MS
Office applications.
- Knowledge of pultrusion
and FEA is a plus.
- US Citizenship
|
|
Quality Engineer
|
Develop and establish Quality Assurance
programs and process control methodologies to provide and maintain the
highest quality levels in support of Product Development Product
Assurance (PDQA) activities. These PDQA activities will be lead by the
Commercial Aviation Systems Business Unit in conjunction with the
Engineering department during the planning, requirements, design/development and verification phases of
Commercial Aviation product development projects. Will perform activities
to assure compliance to all project requirements throughout the development
process life cycle. These activities will be primarily focused on the
development of systems, software and hardware. The person selected for
this position must have an understanding of the Aerospace Industry
standards for software development (RTCA-DO-178B), hardware development
(RTCA-DO-254), and environmental testing (RTCA-DO160D). Requires a
Bachelor’s degree in a technical discipline and 4-6 years of
related experience in an engineering development environment. Business
travel both domestically and abroad will be required.
|
|
Senior Reliability
Engineer – Defense
|
Responsible for performing reliability
Allocations and Predictions (MIL-HDBK-217 & 217F – both parts
count and stress analyses) for both military and commercial programs.
Will also perform Failure Modes Effects Analyses (FMEAs).
The person selected for this position will be responsible for developing
Highly Accelerated Life Test (HALT) profiles and test procedures.
Requires a Bachelor’s degree in Electrical Engineering, Physics,
Mechanical Engineering, Mathematics or related area and 6-8 years of
related experience (at least 5 of which are in the area of Reliability
Engineering). Must be experienced in Reliability Modeling and Automated
Programs.
|
|
Principal Manufacturing
Engineer - Avionics
|
Apply Design for Manufacture and Assembly
(DFMA) and Design to Unit Cost (DTUC) methodology to new development
design. Provide technical leadership and project management in the
development and implementation of methods, systems and procedures for the
manufacture of complex or specialized products, ensuring efficient,
cost-effective manufacturing results.
Apply analytical approach in problem solving. Coordinate manufacturing
project efforts with Methods, Quality, and Facility personnel in establishing
efficient production operations, work place layout, and facilities.
Improving existing operations by incorporating new methods and processes.
Investigate and develop new processes, equipment and methods to reduce
the cost of products or to improve product performance, quality or
delivery, with particular regard for vertical integration. Coordinate
manufacturing engineering activities with the efforts of other functions
such as Production, Purchasing and Material Control for the smooth
transition of new equipment, products and processes into production.
Conduct feasibility studies relative to plans for new or modified
production efforts. Develop manufacturing jigs, tools, fixtures and
methods to meet engineering specifications and provide efficient manufacturing.
Perform other related duties as assigned.
Education and Experience
A Master's degree in engineering or similar discipline and 8 years
related experience to be proficient in the above areas or an equivalent
combination of education and experience. Process development and lean or
six sigma manufacturing background is required.
|
|
Senior Logistics Engineer
– Avionics
|
Seeking an individual who will support
both Military (DoD) and Commercial Programs and
Products. The individual must be a self-starter, who is assertive and who
has demonstrated initiative in completing ILS related tasks. The
individual will work as part of an Integrated Product Team, supporting
Concurrent Engineering activities on Product Development and support
individual tasks on other programs. The individual must be able to work
with Systems and Reliability Engineering to develop ILS and Reliability
Centered Maintenance Programs for Military and Commercial Product Lines.
Experience in MSG-3 (Commercial Avionics) is preferred but not
mandatory.
Responsibilities will include:
• Level of Repair Analysis (LORA)
• Logistics Support Analysis/Reports (LSA/LSAR)
• Level of Spares analysis
• Support Reliability and Tech Manual Tasks
• Support MSG-3 Maintenance Activities (Schedules/Tasks)
• Provide Life Cycle Cost Analyses (LCC)
• Support Proposal activities in the ILS area
|
|
Component Engineer –
Avionics
|
This position requires the individual to
support primarily Commercial Avionics programs with some US DoD and foreign military programs. The position
requires close collaboration with Quality Assurance and Operations. This
positions requires both individual contributions and to work as a part of
a team.
Required Skills/Education:
• Experience with closed-loop failure analysis and FRAIAS
• Evaluate and determine root cause failures on electrical,
mechanical, and electro-optical components
• Determine alternate components due to obsolescence or redesign
• Write ECO’s where required
• Evaluate Bills of Materials for component long-term availability,
select alternates
• Write Source/Spec Control Drawings for specialized components
where required
• Work closely with vendors and Purchasing on selection of
specialized components
• Ability to multi-task on 2-3 projects
• 7-9 years in Component Engineering or related fields
• BS EE or ME or Manufacturing Engineering
|
|
Contract Manager (Supply
Chain)
|
Responsibilities to
Include:
Under the direction of the Director of Procurement to organize, schedule and
administer the activities of a procurement unit involved with
negotiating, placing orders and expediting the delivery of high risk,
high dollar, technologically advanced subassemblies, materials, equipment
and supplies in a DoD procurement environment.
Responsible for all aspects of management leadership and able to work
subcontracts within any area of product life cycle maturity.
Education Requirements:
Bachelors Degree in Business
Position Requirements:
Must be totally capable of managing both major/critical subcontracts and
assigned critical commodities. Thorough knowledge FAR/DoD
Procurement Regulations. Strong quality and problem solving background
including:
-
excellent
knowledge of quality systems/improvement techniques
-
able to work
subcontracts within any area of product life cycle maturity
-
knowledge of
Best Value source selection methods
-
experience at
managing multi-tier supplier chains from vantage point of prime/lower
tier contractor
-
knowledge of problem solving tools such as corrective action,
analysis of supplier date, supplier rating systems.
Direct and indirect budget
management including cost account management. Experience in value
analysis and value engineering/process improvement. Candidate must be
focused on supporting program goals and factory need; future product
development with good strategic sourcing skills. Ability to proactively
lead a multi-disciplined Supplier Base Integration team in the
evaluation, selection, award and continuous improvement of a highly
technical/precision producer base in the delivery of complex mechanical
and electrical product in a DoD procurement
environment. Must be capable of dealing with external and internal
personnel by possessing outstanding interpersonal skills.
|
|
Principal Subcontracts
Administrator (Supply Chain)
|
Job Summary:
Seen as functional experts. Performs advanced analytical,
research-related, and/or consultative activities in order to administer
and/or maintain operations, policies/procedures, and guidelines related
to own function. Analyzes and projects all aspects of department's
performance, prepares analysis of performance and prepares special
studies (i.e. impact, budget, etc.). Requires a broad understanding of
departmental and company techniques, methods, and practices. Acts as
consultant to senior leaders on departmental/corporate initiatives.
Responsibilities to Include:
· Responsible for development/design and implementation of new
or revised departmental policies/procedures, programs, techniques,
methods, and functionally-related initiatives.
· Develops and presents proposals.
· Responsible for allocating work to and providing guidance to
lower-level employees.
· Generates Request for proposal,
performs fact finding, cost/price analysis, negotiates subcontract price/terms,
and develops Long Term Agreements as required.
· Identify and support continuous improvement initiatives.
· Support Six Sigma and lean activities internally and at
the subcontractor.
Education:
Bachelors degree in Supply Chain Management or other related
field; Masters degree preferred.
6+ years Subcontract/
Supplier Management and manufacturing experience with involvement in the
procurement of high dollar, complex assemblies and critical commodities.
|
|
Logistics Manager
|
Manage, schedule, budget,
monitor and implement all equipment and spares to all field sites
(35). Coordinate with Lexington
Division operations for materials scheduled for San Jose distribution. Extensive interface with government inspectors
for quality issues, government property control programs and related
property sequence. Should know
FAR/ISO regulations. Will be
located in San Jose facility with
long-term opportunity to join the Lexington
team.
|
|
Manufacturing Engineer
(Sensors)
|
Support manufacturing in
design, development and certification of new and existing procedures and
equipment. The engineer will be responsible for leading task teams into
the investigation and control of all sources of product variability.
Process engineer for GTAW
(TIG), thermal processes and leak detection, welding of stainless steel
and Inconel alloys. Able to develop weld
schedules for semi-automatic equipment using both torch and orbital
welding. Knowledge of basic vacuum technology and Helium leak checking.
ME degree and 5-10 years
experience.
|
|
|
|
|
|
|
|
|
