HW3
Job Title: Director/Sr. Director of Manufacturing Engineering
Status: Full Time Exempt
Amount of Travel Required: up to 25%
Work Schedule: Full-time
Positions Supervised: Senior Manufacturing Engineer, will grow a team
POSITION SUMMARY The Manufacturing Engineer leads volume scale-up and commercialization build activities for the company’s Class II device(s). This individual is responsible for manufacturing process development (in conjunction with R&D), design transfer and manufacturing process validation. This position works closely with production, R&D, RA/QA to drive product initiatives.
Key Attributes
Highly visible, high-impact
role — the hire will effectively build the Manufacturing Engineering team that carries them through FDA approval and commercial launch.
Combination product complexity
— requires understanding of
orthopedic implants AND/OR electromechanical pumps
(infusion, negative pressure, or similar systems). (Class II or III).
Start-up pace and variety
— this is a nimble organization, so you’ll wear many hats, and work cross-functionally.
Hands-on and strategic
— the Manufacturing roles will get into the details of process validation while also helping shape the department’s long-term structure.
Core Responsibilities
Lead and execute
design transfer
activities from R&D to manufacturing. — looking for someone who has
“Been there, done that”
— experience bringing a medical device or combination product from design through launch.
Own
process validation ,
manufacturing documentation , and
supplier readiness
for commercial launch.
Strong background with
contract manufacturers
and outsourced production.
Partner with Quality and Regulatory to ensure
GMP and FDA submission
alignment.
Support
sustaining manufacturing
and continuous improvement once commercial production begins.
Collaborate with Supply Chain to ensure
manufacturing capacity
meets product demand.
#J-18808-Ljbffr
Status: Full Time Exempt
Amount of Travel Required: up to 25%
Work Schedule: Full-time
Positions Supervised: Senior Manufacturing Engineer, will grow a team
POSITION SUMMARY The Manufacturing Engineer leads volume scale-up and commercialization build activities for the company’s Class II device(s). This individual is responsible for manufacturing process development (in conjunction with R&D), design transfer and manufacturing process validation. This position works closely with production, R&D, RA/QA to drive product initiatives.
Key Attributes
Highly visible, high-impact
role — the hire will effectively build the Manufacturing Engineering team that carries them through FDA approval and commercial launch.
Combination product complexity
— requires understanding of
orthopedic implants AND/OR electromechanical pumps
(infusion, negative pressure, or similar systems). (Class II or III).
Start-up pace and variety
— this is a nimble organization, so you’ll wear many hats, and work cross-functionally.
Hands-on and strategic
— the Manufacturing roles will get into the details of process validation while also helping shape the department’s long-term structure.
Core Responsibilities
Lead and execute
design transfer
activities from R&D to manufacturing. — looking for someone who has
“Been there, done that”
— experience bringing a medical device or combination product from design through launch.
Own
process validation ,
manufacturing documentation , and
supplier readiness
for commercial launch.
Strong background with
contract manufacturers
and outsourced production.
Partner with Quality and Regulatory to ensure
GMP and FDA submission
alignment.
Support
sustaining manufacturing
and continuous improvement once commercial production begins.
Collaborate with Supply Chain to ensure
manufacturing capacity
meets product demand.
#J-18808-Ljbffr