Job Description

This is a remote position.

We are seeking a talented and self-driven R&D Engineer to support the design, development, and optimization of innovative medical devices and life sciences systems. This role requires a balance of technical expertise, creativity, and regulatory discipline transforming clinical and user requirements into safe, functional, and compliant product designs. The ideal candidate combines strong engineering fundamentals with an understanding of FDA, ISO 13485, and ISO 14971 requirements, collaborating with cross-functional teams to deliver high-quality, manufacturable, and regulatory-compliant medical technologies that improve patient outcomes.
Key Responsibilities
Lead and contribute to the end-to-end product development lifecycle, from concept and feasibility to design transfer and commercialization.
Develop 3D models, detailed drawings, and engineering documentation using CAD software (e.g., SolidWorks, Creo) to support mechanical and electromechanical device design.
Conduct design verification and validation (V&V) testing, analyze data, and generate technical reports that demonstrate compliance with applicable standards and requirements.
Collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure design activities align with Design Control (21 CFR 820.30) and risk management standards (ISO 14971).
Participate in risk analyses (FMEA, DFMEA, PFMEA), hazard assessments, and mitigation strategies throughout the product lifecycle.
Support prototype fabrication, bench testing, and design iteration, translating test results into actionable design improvements.
Work with Manufacturing Engineering to ensure Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) readiness.
Prepare and maintain Design History File (DHF) documentation and ensure compliance with ISO 13485 quality system requirements.
Support the design transfer process, including pilot builds, process validations, and technical documentation for production release.
Contribute to continuous improvement initiatives, applying statistical methods, Lean, and Six Sigma principles to enhance design efficiency and product quality.
Must-Have Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical field.
Professional experience in medical device product development, including exposure to design controls, risk management, and validation.
Strong proficiency with CAD tools (e.g., SolidWorks, Creo, or equivalent) and engineering documentation practices.
Working knowledge of FDA Design Control (21 CFR 820), ISO 13485, and ISO 14971.
Demonstrated ability to execute V&V testing, data analysis, and root cause investigations.
Excellent technical writing and documentation skills with attention to regulatory compliance.
Strong collaboration and communication skills with cross-functional project teams.
Preferred Qualifications:
Experience developing electromechanical systems, implantable devices, or disposable medical products.
Familiarity with materials selection, sterilization validation, and biocompatibility testing.
Exposure to process development, design transfer, and manufacturing scale-up.
Proficiency in finite element analysis (FEA) or tolerance stack-up analysis.
Knowledge of ISO 60601, IEC 62304, or EU MDR requirements.
Experience working in Agile or phase-gated product development environments.
Certification in Lean Six Sigma, ASQ CQE, or PMP is a plus.

This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.

About Pharmavise Corporation

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.

𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:

We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.

𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:

☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.

☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.

☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.

𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆

Over 20 Technical Transfers and 30 product launches.

11 FDA remediations. Warning Letters and or Consent Decrees.

Cost savings and increased efficiency of over 10MM for clients

Industry

Consulting & Advisory

Company Size

11-50 employees

Headquarters

Fort Lauderdale, Florida

Year Founded

2013

Website

pharmavise.com

Social Media