IntePros ยท 21 hours ago
Senior Director, NPI Engineering
Philadelphia, PA
Full-time
Onsite
Director/Executive
7+ years expIntePros is currently looking for a Senior Director, NPI Engineering to join one of our growing Medical Device/Manufacturing clients in Philadelphia, PA. The Senior Director will lead the engineering team overseeing process engineering, project engineering, capacity management, and capital management, ensuring compliance with pharmaceutical and medical device regulations while driving continuous improvement and efficiency.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Oversees NPI engineering project management
Supervises a staff of engineers and/or engineering technicians and provides guidance, leadership, and mentorship in areas of engineering, project management, and professional development
Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan
Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements
Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by site Project Managers
Adapts NPI engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring
Communicates significant equipment or process issues to site leadership
Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues
Ensure effective communication, planning and coordination between other functions
Prepares equipment/engineering estimates for potential projects (to be submitted to sales)
Analyzes sales requests to determine equipment, tooling, or delivery systems needed
Oversee the Engineering review of all components for new jobs (size, capability of equipment, bar codes)
Conducts and/or participates in customer meetings and attends occasional off-site meetings
Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering
Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology
Coordination of outside design, integration, and equipment manufacturing services
Manages the site facilities and utilities to accommodate new equipment and meet all regulatory requirements
This position may require overtime and/or weekend work. Knowledge of and adherence to all client, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor
Qualification
Required
Bachelor's Degree in Engineering or related field
7-10 years experience in a related industry
College Level Mathematical Skills
Program and Project management
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms
High standard of report writing
Preferred
Ability to adapt to changing work environments
Ability to effectively present information to various people as the job requires
Ability to work independently and/or as part of a team
Ability to display excellent time management skills
Lean/Six Sigma training
GAMP5 experience with drug-device assembly processes
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
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