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Job Description The Director/Sr. Director, Design Engineering
will be based at our Dallas, TX site. This role will provide
overall management of the Dallas Design Center’s Design and
Development Engineering operations, including mechanical
engineering, systems engineering, electrical engineering and
software/firmware engineering functions. This key role, as a member
of the site leadership team, will be challenged to effectively lead
the design and engineering resources required to support the growth
of the medical contract design and manufacturing business segment
through the successful development, validation and implementation
of innovative and cost-effective new product solutions for our
customers. You will oversee significant improvement in site
capability, culture, and drive towards developing a world class
engineering organization. The role will be responsible for
implementing and coordinating engineering procedural quality
improvement program(s), intended to prevent or eliminate defects in
new product programs, through the development and management of
people and processes. This is a high visibility role and will allow
the person hired to make a difference in our product development
predictability, execution and outcomes while building a world class
We are looking for someone who demonstrates:
Passionate customer focus
Thoughtful, fast, disciplined execution
Tenacious commitment to continuous improvement
Relentless drive to win
Here is a glimpse of what you’ll do:
Provide oversight of the site Design Engineering function.
Ensures the comprehensive completion of design controls compliance,
risk management, Design and Development engineering plans, and
meeting on-time/on-budget metrics for all customer development
Direct and control the activities of a broad functional area
through several senior Design & Engineering managers involved in
activities such as designing, developing, modifying and evaluating
mechanical, electrical, systems and software for medical equipment
Provide technical and strategic guidance to subordinates to
ensure achievement of program goals and objectives, while ensuring
budget, schedules and customer outcomes are met.
Partner with other site LT members to establish site-wide goals,
objectives and action plans. Provide tactical guidance to
subordinates to ensure achievement of goals and objectives focused
on continuous site improvement.
Report progress on design issues and improvement programs to
customers as required. Maintain contact with customers to ensure
their business needs are met or exceeded.
Develop and continuously improve people, methods, systems,
processes and metrics in a complex and rapidly changing environment
to improve product cost, quality, delivery and service levels
resulting in increased customer satisfaction.
Manage Design Engineering staff by providing coaching,
counseling, planning, mentoring, etc. Establish measurable employee
goals and perform appraisals through quarterly assessment and
annual performance reviews.
Organize and lead oversight, training, and direct review of
design engineering outputs to ensure projects are delivered on
time, per cost targets, and all engineering documents and records
related to implementation are in compliance with all medical
regulations (i.e. CFR 820, ISO 13495, et al.).
Partner with PMO, Quality and NPI leaders to ensure all design
and engineering activities are well integrated with NPI and
Manufacturing Operations site teams. Manage resources among
competing departments, customers and projects.
Play a key role on the team chartered with preparing and
developing customer program proposals, including timelines,
budgets, deliverables, etc. Support generation and delivery of
customer proposal presentations.
Represent Design Engineering in customer-facing meetings
including but not limited to RFQ workshops, SOW reviews, Joint
Steering Committees, proposal presentations, etc.
Hire, train and develop technically outstanding Design Engineers
and other design professionals to provide high quality deliverables
to our customers.
Here is some of what you’ll need (required):
15 years of experience in medical devices or invitro-diagnostic
Bachelor’s degree in an engineering discipline, preferably
Dynamic, energetic leader with a minimum 10 years of experience
in progressive management roles up to and including Director or Sr.
Experience in Medical Device Design and Development, Mechanical
Engineering, Systems Engineering, Electrical Engineering and
Extensive full product life cycle experience with a proven track
record of successful development and commercialization of complex
medical devices and systems.
Experience in process validation of high volume / automated
manufacturing lines, molding operations, and sterilization
Extensive understanding and application of FDA 21 CFR Part 820
(including design controls) and all associated regulations and
guidance related to medical device manufacturing and ISO13485
Experience managing major, complex development programs and
teaming with customers and business partners to start up new
medical product development and manufacturing projects.
Excellent judgment and decision-making capability – both
technical and practical.
Experience working under clean room and environmental control
conditions. In addition, experience in one or more sterile
packaging technologies, sterilization methods and release of
Demonstrated skills in complex program management having
competing priorities, and ability to train others to lead
Proposal development & quote generation, customer presentation
and engagement experience.
Integrity, judgment, and the ability to hold one’s ground under
Proven experience achieving results through others and managing
a wide experience range of individuals.
Strong technical analytical skills including FMEA, statistical
methods, and Six Sigma techniques, etc.
Ability to develop, implement, manage and control departmental
financial budget. Ability to contribute to site level financial
forecasting and achievement of site revenue and profitability
Here are a few of our preferred experiences:
Ability to work in a multinational, multicultural and highly
Systems Engineering background with emphasis on Mechanical
Strong customer and product quality focus.
Ability to think strategically when problem-solving.
Engineering development performance track record in a medium to
large-scale contract medical device product development and
manufacturing site is preferable.
Highly proficient in Microsoft Office Suite and MS Project
Here are a few examples of what you’ll get for the great work
Full range of medical benefits, dental, vision
Employee discounts at local retailers
Job Category Design, Process & Technology Engineering Flex does
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Posted 2 Days Ago
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• Industry: Electrical/Electronic Manufacturing