PRODUCT ENGINEER We are seeking a proactive and skilled Product Engineer with hands-on experience in the industry to join our fast-growing diagnostics company.
You will support both R&D and Operations activities while growing as an individual contributor within the team.
Becoming a key contributor in the development, manufacturing transfer, and market support of handheld medical devices, helping us to meet the needs of a rapidly expanding customer base.
A highly motivated and self-managing engineer with experience working in customer-focused commercial environments.
The role will require you to join a tight-knit team to develop and manage products for a growing customer base.
Working closely with a multidisciplinary team of engineers, scientists, and regulatory professionals to design, develop, and bring a cutting-edge medical device to market.
The ideal candidate will be eager to learn, enthusiastic about the medical device industry, and committed to the highest standards of quality and innovation.
Key Responsibilities: Participate in the design, development, and testing of new medical devices, ensuring timely progression from concept to production.Oversee the development of engineering documentation, including specifications, design verification plans, validation protocols, and technical reports.Collaborate effectively with cross-functional teams, including Quality Assurance, Manufacturing, and Regulatory Affairs, to ensure compliance with industry standards (ISO 13485, FDA).Manage product validation, risk management activities (FMEA, Risk Benefit Analysis), and ensure products meet safety, performance, and regulatory requirements.Provide technical expertise in the transfer of products from R&D to manufacturing, supporting production scale-up and continuous improvement initiatives.Lead troubleshooting efforts for technical challenges during development and production phases, implementing effective solutions.Support market and post-market product improvements, assisting with customer feedback, issue resolution, and product lifecycle management.Stay informed about the latest medical device technologies, industry trends, and regulatory changes to ensure ongoing innovation and compliance.Qualifications and Skills: Bachelor's or Master's degree in Mechanical, Electronic, Computing, Software, Mechatronic, or Biomedical Engineering, or a related field.Proven experience in CAD software (e.g., SolidWorks, AutoCAD) and finite element analysis.Working knowledge of medical device regulatory standards, including ISO 13485, FDA guidelines, and risk management practices (FMEA).Excellent communication and interpersonal skills to manage cross-functional teams and work collaboratively.Demonstrated problem-solving abilities and a proactive approach to overcoming technical challenges.A passion for innovation and a commitment to improving healthcare outcomes through cutting-edge technology.Why Join Us? Be part of an innovative and fast-growing company that values creativity.Work in a dynamic, collaborative team environment with access to senior leadership and opportunities to shape the future of our products.Opportunity to contribute to ground-breaking medical technologies that have a positive impact on global healthcare outcomes.
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