Senior R&D Chemist / Analyst
The Senior R&D Chemist/Analyst will work closely with a cross-functional team to develop an innovative medical device solution while ensuring compliance with regulatory, design control, and end-user requirements.
Key Responsibilities:
* Lead the design, development, testing, and manufacturing of novel medical device products.
* Develop and validate analytical test methods.
* Identify and implement innovative design and process solutions to address complex clinical needs.
* Develop and manage detailed project plans covering design, quality, regulatory, and design control requirements.
* Lead risk management activities for assigned product development areas.
* Compile and manage technical reviews, ensuring accuracy and regulatory compliance.
* Write and review technical reports, test protocols, and validation documentation.
* Oversee the transition of products from development to manufacturing.
* Analyze complex data sets and distill insights to drive device design improvements.
* Develop and execute research programs and project plans within established timelines.
* Propose innovative solutions to technical challenges and contribute to continuous learning.
* Communicate key insights and recommendations to influence technical strategies and decision-making.
* Perform additional duties as requested by management or the supervisor.
Requirements:
* Bachelor's degree in Life Sciences or Engineering discipline with 5+ years of experience in analytical method development and validation for medical devices.
* Advanced qualifications (MSc, PhD) in medical device technology are advantageous but not essential.
* Strong understanding of medical device regulatory requirements for design and development activities.
* Proficiency in SolidWorks for models, drawings, and assemblies.
* Expertise in engineering/analytical tools such as Excel, MATLAB, and Microsoft applications.
* Experience in medical device development and/or biodegradable implants is desirable.
* Knowledge of Waters Empower software.
* Strong communication and collaboration skills at all levels of an organization.
* Ability to build positive relationships both internally and externally.
* Willingness to travel and work on client sites for analytical transfers.
About You:
You are a driven and innovative professional with a passion for advancing medical device technology. Your strong analytical skills, problem-solving mindset, and ability to manage complex projects make you a valuable contributor to any development team.
About Us:
We offer a competitive salary and benefits package, opportunities for professional growth in a leading-edge industry, a collaborative, high-performance team dedicated to innovation and excellence, and the chance to work on groundbreaking medical device solutions with real-world impact.
Diversity and Inclusion:
Diversity and inclusion are essential to our mission and achieving our vision. We are an Equal Opportunity Employer.