Job ID: JOB_ID_997
Role Overview
We are seeking a dedicated and highly skilled R&D Engineer to join our medical device development team in Franklin Lakes, NJ. This role is pivotal in the design and validation of next-generation medical technologies that impact patient outcomes globally. With 6-8 years of specialized experience, the candidate will lead technical projects through the rigorous phases of the product development lifecycle, ensuring that every innovation meets the highest standards of safety, efficacy, and regulatory compliance. The R&D Engineer acts as a technical lead, coordinating between design teams, manufacturing, and regulatory bodies to bring life-saving products from concept to market.
Key Responsibilities
- Plan and execute comprehensive validation and verification activities in strict alignment with ISO 13485 and ISO 14971 standards.
- Oversee daily operations and project milestones at the client location, serving as the primary technical link between the client and the internal project team.
- Lead New Product Development (NPD) initiatives, focusing on innovative design solutions and material selection for medical applications.
- Manage Design Change Management processes, ensuring all modifications are documented and validated according to Quality Management System (QMS) protocols.
- Direct Product Life Cycle Management (PLM) activities, from initial feasibility studies to post-market surveillance support.
- Conduct detailed Risk Management activities, including the development of FMEAs (Failure Mode and Effects Analysis) and hazard assessments.
- Design and implement Design Verification and Validation (V&V) protocols to ensure products meet all predefined functional and safety requirements.
- Collaborate with cross-functional teams to ensure design outputs are consistent with design inputs and user needs.
- Maintain meticulous technical documentation and design history files (DHF) to support regulatory submissions.
Qualifications and Domain Expertise
The ideal candidate must have a mandatory background in the medical devices domain. Deep familiarity with FDA regulations and international standards such as ISO 13485 is non-negotiable. Technical proficiency in CAD software (SolidWorks or similar), statistical analysis (Minitab), and project management tools is required. The role demands a proactive problem-solver who can navigate the complexities of design controls and risk-based decision-making. A Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related discipline is required. Excellent communication skills are essential for managing client relationships and leading multidisciplinary project teams in a fast-paced, highly regulated environment.
Special Requirements
Prior experience in medical devices domain is mandatory; Knowledge of ISO 13485 and ISO 14971 required.
Compensation & Location
Salary: $130,000 – $170,000 per year (Estimated)
Location: Franklin Lakes, NJ
Recruiter / Company – Contact Information
Recruiter / Employer: Scalable Systems Inc
Email: ankit.dubey@scalable-systems.com
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