Job Title
Senior Technical Lead / Research Associate Renal PD Solutions (Sustaining R&D | Medical Devices & Drug-Device Combination Products)
Job Summary
We are seeking an experienced Senior Technical Lead / Change Owner to drive product design changes, global registrations and launch activities for Renal Peritoneal Dialysis (PD) solutions within the Sustaining Product Organization. This role will act as the technical owner for design and lifecycle changes of marketed and in-development products supporting dialysis treatment and intensive care, ensuring compliance with global regulatory, quality and design control requirements.
Key Responsibilities
- Act as Technical Lead / Change Owner for product design changes and new product registrations for Renal PD solutions in compliance with applicable international, regional and national regulations and standards.
- Define, organize, plan and execute all technical activities related to design changes, labeling updates, raw material changes, manufacturing support and regulatory submissions.
- Provide technical assessment and change strategies for product and process modifications, working closely with senior scientists and cross-functional partners.
- Lead and coordinate technical activities across R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain and Marketing in line with project commitments and business priorities.
- Support global regulatory authorities by preparing and providing timely technical responses and clarifications.
- Propose technical options, develop risk-based action plans, and drive problem-solving and continuous improvement initiatives for products and processes.
- Establish, maintain and update technical files and design documentation in accordance with Good Documentation Practices (GDP) and design control requirements.
- Actively contribute to global and cross-functional project teams, ensuring strong alignment and execution.
- Ensure effective stakeholder communication and provide regular status updates on technical activities, risks and timelines.
Required Qualifications
- Strong knowledge of Renal Peritoneal Dialysis (PD) therapies and products.
- Solid understanding of product development stages, product life cycle management and design control processes.
- Working knowledge of international, regional and national medical device and combination-product regulations and standards.
- Ability to manage multiple parallel projects and dynamically adjust priorities based on business needs.
- Proven ability to work independently, take ownership and drive deliverables to completion.
- Demonstrated problem-solving skills with the ability to develop technical solutions and recommendations in collaboration with senior scientific and technical experts.
- Strong verbal and written communication skills with experience working in global and cross-functional environments.
Key Skills & Experience
- Master's degree in Chemistry, Pharmacy, Biomedical Engineering, Chemical Engineering, Development Engineering or equivalent scientific/engineering discipline.
- 9+ years of relevant experience in medical device and/or pharmaceutical / drug-device combination product R&D.
- Hands-on experience in sustaining engineering, product change management or post-market product support.
- Proven experience in technical project coordination and cross-functional execution.
- Experience working in regulated environments supporting global product registrations and lifecycle changes is highly preferred.
Preferred Experience
- Experience with dialysis or renal therapy products, preferably Peritoneal Dialysis (PD).
- Exposure to labeling changes, design updates, manufacturing change support and regulatory submissions for marketed medical products.
- Experience working with global health authorities and notified bodies.
Why This Role
This position offers a unique opportunity to play a critical technical ownership role in sustaining and improving life-saving renal therapy products, while directly supporting global compliance, patient safety and product quality across international markets.
