Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Lead translation of customer User Needs (UN) into a defined container closure and device strategy, aligned to dosing, patient population, and route of delivery.
- Own Label & Packaging design activities, including DFM (Design for Manufacturability) of packaging and linkage with the Design Lab for concept development and iteration.
- Direct device assembly and test process design, from concept samples through DV (Design Verification) samples.
- Define and deploy scale-appropriate automation strategy, ensuring solutions are right-sized to program volume and maturity (clinical vs. commercial scale).
- Establish assembly in-process control and inspection concepts to ensure consistent build quality. Oversee metrology strategy supporting lot release and regulatory submission data packages.
- Drive a "Right First Time" validation philosophy, ensuring DFM interventions remove sources of variability prior to Qualification (Qual) activities.
- Embed and maintain ISO 14971 risk management across the full product life cycle, from development through post-market.
- Provide technical leadership for regulatory strategy, and support 510(k) and combination product submissions in partnership with Regulatory Affairs and QA.
- Provide technical leadership for regulatory strategy, and support 510(k) and combination product submissions in partnership with Regulatory Affairs and QA.
- Lead cross-functional device RCA investigations, applying in-depth device knowledge, high-speed camera analysis, CT scan, and X-ray imaging techniques to diagnose functional and mechanical failures.
- Translate RCA findings into robust control plans aligned to ISO 14971 risk management principles.
Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Independent business leader, strong team leading skills, no direct personnel supervision. Liaisons with key stakeholders across the organization and external OEMs to realize successful outcomes.
The Director will represent the RTC in client-facing technical discussions, proposal development, and program governance, translating complex device engineering activity into clear risk, timeline, and investment narratives for pharma partners.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
- Stationary Position: Under a 1/4 of the day.
- Move, Traverse: Up to 1/4 of the day.
- Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
- Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
- Ascend/Descend or Work Atop: None.
- Position self (to) or Move (about or to): Up to 1/4 of the day.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: From 1/4 to 1/2 of the day.
On an average day, the individual can expect to move and/or transport up to 10 pounds
less than 1/4 of the day.
This position may have the following special vision requirements.
- Close Vision • Distance Vision • Color Vision • Peripheral Vision • Depth Perception
- Ability to focus ☒ No Special Vision Requirements
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
- Work is primarily performed at a desk and/or in an office environment. For 3/4 of the day and up.
The noise level in the work environment is typically, quiet.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:- Bachelor's degree in Mechanical, Electronic, Biomedical, or Manufacturing Engineering (advanced degree preferred).
- 5+ years' experience in combination product / drug delivery device development, with at least 3 years in a senior leadership role.
- Demonstrated expertise in autoinjector, pen injector, or needle safety device design, assembly, and industrialization.
- Strong working knowledge of ISO 11608, ISO 11040, ISO 14971 and the Metrology equipment to meet it, ISTA/ASTM transport standards, and design controls (DHF/DMR).
- Experience supporting 510(k) submissions and combination product regulatory pathways (FDA, EU MDR/CTR as applicable).
- Track record of building or leading a technical center, lab, or center of excellence supporting external pharmaceutical clients.
- Hands-on familiarity with root-cause investigation tools (CT scan, X-ray, high-speed imaging) and automation/tooling program management.
- Strong client-facing communication skills; comfortable operating at both technical depth and executive summary level.
- Able to translate customer feedback into meaningful product solutions, is a self-motivated multitasker with high attention to detail.
- Track record in developing and executing product launches
- Efficient with a focus on timelines & due dates
Preferred:- Experience with device platform partnerships and managing external SME networks.
- Familiarity with DFM/DFA methodologies and statistical process control in a regulated manufacturing environment.
- Experience managing multi-program portfolios across clinical and commercial stage clients simultaneously.
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