Sr Product Engineer

Pay 50-53/h depending on experience Product Development & Engineering Lead end-to-end product development activities including design, prototyping, testing, and validationDrive technical decisions and provide engineering expertise throughout the product lifecycleDevelop and review engineering specifications, design documents, and technical reportsIdentify and resolve complex engineering challenges using systematic problem-solving approachesCross-Functional CollaborationPartner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignmentServe as a technical resource and mentor for junior engineersCommunicate technical concepts clearly to both technical and non-technical stakeholdersProject LeadershipLead or contribute to multiple concurrent engineering projectsDefine project scope, timelines, and deliverablesTrack milestones and proactively manage risks and dependencies Quality & ComplianceEnsure products meet regulatory requirements (e.g., ISO, FDA, MDR) and internal quality standardsSupport design verification and validation (V&V) activitiesParticipate in design reviews, FMEAs, risk assessments, and change control processesContinuous ImprovementIdentify opportunities to improve products, processes, and engineering practicesApply data-driven methods to analyze performance and drive decisionsStay current with industry trends, emerging technologies, and best practices Requirements: B.S. in Mechanical, Electrical, Biomedical, or related Engineering field Bachelor's degree or higher in Life Sciences or related discipline Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry. Experience implementing or improving ISO 13485-based QMS. Strong experience working with Singapore medical device regulatory requirements. Demonstrated experience supporting or leading GDPMDS/GDP certification projects. Proven track record of successfully helping organizations obtain and maintain GDP certification Experience interacting with certification bodies, accreditation bodies, and regulatory authorities. Technical skills: 5-8+ years of product engineering experienceValidation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820