Senior Engineering Manager
3 weeks ago
Senior Engineering Manager of Product Design/Manufacturing
Company Overview:
Our client is a leading innovator in the medical device sector, specializing in unique surgical solutions. With its revolutionary technology, the company is redefining medical innovation boundaries.
Are you an Engineering Leader with a passion for
groundbreaking
solutions and a desire to be part of charting new territory?
If so, wed love to connect.
Position Overview
This is a player/coach role, providing technical leadership for product design and manufacturing teams. Take
concepts
from R&D and implement functional, manufacturable, cost-effective product designs and associated manufacturing processes. Lead
product design
and
manufacturing teams
to successfully
transition new products
into manufacturing, consistent with medical product regulatory standards and Good Manufacturing Practices.
Work closely with the R&D team to support product
concept development
and
prototype builds . Work closely with the Quality team to ensure all product, process, training, and qualification documentation is
complete
and
compliant
with
regulatory requirements . Work closely with the Operations team to support the build schedule and implement
product
and
process improvements . Work closely with the Finance/Accounting team to support business system implementation and achieve COGS targets. Provide
technical and organizational leadership
for the PD and manufacturing technical team.
PRIMARY RESPONSIBILITIES
Provide technical leadership
for product design and manufacturing engineering activities.
Work both independently and in cross-functional teams
developing, troubleshooting, and standardizing the design, manufacture, and test methods for novel products including the improvement of existing test methods and procedures.
Lead product and process improvement
projects, including engineering change management, product cost reduction, manufacturing process improvement, tool/fixture development, equipment sourcing and implementation, PM, training, etc.
Define and implement processes , systems, and documentation needed to produce products, including:
CAD software, traditional and additive manufacturing technologies, and good engineering drawing practices to design, build, and document test and manufacturing processes, tooling, and fixturing.
Manufacturing processes, routers, specifications, inspection procedures, etc. for manufacturing according to GMP, ISO, and FDA requirements.
Maintenance of all equipment, tooling, and fixtures used in manufacturing.
Packaging and sterilization operations.
Lead production activities
during pilot production phases, including:
Batch builds for prototypes, testing, clinical studies, and early sales.
New supplier identification, evaluation, and qualification.
Verification and validation testing.
Supplier orders and inventory management.
Production scheduling and execution.
Work closely with R&D, Operations and Quality
on all projects and day-to-day activities.
QUALIFICATIONS, EDUCATION & EXPERIENCE
Bachelors degree in relevant engineering disciplines (mechanical, manufacturing systems, etc.).
8-10 years experience in transitioning new products from R&D to manufacturing.
8-10 years experience in the medical devices/products industry
5 or more years leading teams with direct people management responsibilities (>2 direct reports).
SolidWorks CAD experience.
Experience in using sound engineering judgment and analytical skills to conduct root cause analysis to solve engineering problems.
KNOWLEDGE, SKILLS, AND ABILITIES
Strong verbal and written communication skills with the ability to communicate ideas to all levels of the organization.
Ability to work in office, lab, and production floor environments.
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