Company Description

Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.

Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. You would be joining a company committed to “make it better” every day, for our customers and for our employees.

Role Description

The DHF Process Engineer will play a critical role in ensuring the quality and regulatory compliance of medical device products throughout their lifecycle - from concept through to commercialization. This position is responsible for leading and project managing design control activities in accordance with ISO 13485, ISO 14971, UKCA, EU MDR, MDSAP, FDA and other applicable standards. Working cross-functionally with engineering, manufacturing, regulatory, technical and supply chain teams, the DHF Process Engineer will ensure that product development processes and documentation is robust, audit-ready, and aligned with internal procedures and external requirements. This role is essential in supporting the generation of regulatory submission content and ensuring product safety, performance, and compliance at every stage of development.

Responsibilities

• Develop, compile, and maintain Design History Files (DHF), Technical Files, and related documentation throughout the product development lifecycle.
• Ensure design and development documentation meets internal quality standards and regulatory requirements (e.g., 21 CFR Part 820, ISO 13485).
• Create and manage documentation such as design plans, design inputs and outputs, risk management files, verification and validation reports, design reviews, and device master records.
• Assist with creating/ updating raw material and finished product specification sheets.
• Support the preparation and maintenance of Technical Files for CE marking and international registrations.
• Work cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to collect and integrate necessary documentation.
• Coordinate Design Control activities simultaneously to ensure timely, compliant documents are generated to support Tech File submissions for new product launches
• Maintain document control systems, including version control, approval workflows, and archiving per company procedures.
• Review and edit technical content for accuracy, completeness, and compliance.
• Support internal and external audits and inspections by providing required documentation and addressing any document-related findings.
• Assist in the continuous improvement of documentation processes and templates to increase efficiency and ensure compliance.
• Train staff on documentation and DHF best practices as needed.

Requirements:

• Degree in Science, Engineering or related technical field (or equivalent experience)
• At least 5 years’ experience working in Design Control, within the Medical Device Industry
• Demonstrable experience of contributing to/leading Design Control activities, DHF management
• Knowledge of ISO 13485, IS0 14971, UKCA, EU MDR, MDSAP, FDA regulatory standards and Design Control Principles
• Demonstrated training/competence in applicable regulatory frameworks
• Proven regulatory authorship and leadership experience

ADDITIONAL SKILLS, KNOWLEDGE OR ATTRIBUTES

• Excellent communication skills with the ability to lead cross functional teams at project meetings
• Ability to foster a collaborative working environment
• Ability to work independently and collaboratively
• Capability to manage competing priorities simultaneously

If you are passionate about engineering solutions that make a difference in patient care, we invite you to apply for the Process Engineer position at Gentell and be part of our innovative team!