Senior Device Engineer

Location: Hampton

Overview

Join our growing Manufacturing team at Celldex as we enter an exciting phase of our company. The Senior Device Engineer will drive the end-to-end development of a device combination product within our Immunology/Inflammation therapeutic areas. The position will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi-functional collaboration with internal and external partners, for the combination product device.

Responsibilities

* Sourcing Human Factors Consultants to execute Human Factors Studies

* Manage the device design and development lifecycle of a combination product development.

* Defines product requirements and specifications with commercial, clinical, and other development/strategy collaborators.

* Responsible for all user needs and requirements to be validated through design and development.

* Develops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members.

* Integrate device development activities with CMC and Global development timing and goals.

* Leads all aspects of product testing for the specific device development.

* Manages the development and the updates to the Design History File (DHF) to meet regulatory and quality requirements (21

CFR Part 3 and 21 CFR 820.30).

* Drafts the regulatory device development sections (ie: IND/IMPD, BLA Submission, etc.)

* Supports and generates timelines for the device development and launch activities of a new combination product.

* Manage device verification testing to support functional (EDDOs) release and stability requirements.

* Ensure compliance and quality by working with Celldex Quality team

Qualifications

* Bachelor's degree in a science-related field - Engineering preferred.

* 8+ Years of experience in device and integrated combination product development, including comprehensive understanding of pharmaceutical and delivery system processes.

* Proven experience with pre-filled syringes and autoinjectors in a regulated environment, is a plus

* Experience in developing and implementing process changes and improvements for combination products or medical devices.

* Possess strong project management and interpersonal skills and strong analytical and problem-solving capabilities.

* Can work effectively across multiple functional teams.

* Enjoys working in a fast-paced, multifaceted research and development environment.

* Willing and able to travel less than 10% to investigate partners, perform audits, and for project coordination activities.

* Proficient in Word, Excel, PowerPoint, and Share Point

* Excellent communication, problem-solving, and project management skill

Compensation

The expected base salary range for this position is $133,579 to $173,480.

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.