Team Leadership & Development:
o Lead, mentor, and motivate a team of engineers, fostering their professional growth and development.
o Conduct performance reviews, provide constructive feedback, and identify training needs.
o Drive recruitment efforts to build a high-performing engineering team.
Project Management & Execution:
o Oversee the full lifecycle of engineering projects from concept to commercialization, ensuring projects are delivered on time, within budget, and meet specified requirements.
o Define project scope, objectives, and deliverables in collaboration with cross-functional teams (e.g., R&D, Product Management, Manufacturing, Quality, Regulatory Affairs).
o Implement and optimize agile development methodologies or other relevant project management frameworks.
o Identify and mitigate technical and project risks.
Technical Oversight & Strategy:
o Provide technical guidance and expertise, ensuring sound engineering principles and best practices are applied.
o Drive architectural decisions and technical roadmaps for product development.
o Ensure compliance with relevant industry standards and regulatory requirements (e.g., FDA, ISO 13485, GMP) applicable to medical devices or IVD products.
o Champion innovation and explore new technologies and methodologies to enhance product performance and development efficiency.
Innovation & Custom Design:
o Drive the development of innovative solutions and technologies that align with strategic business goals for Dry reagent & Biochemistry manufacturing.
o Oversee the entire life cycle of custom design products, from concept through to successful implementation, ensuring they meet client specifications and quality standards.
o Collaborate with sales, marketing, and product management to understand market needs and translate them into engineering requirements for new and custom products.
Cross-functional Collaboration:
o Act as a key liaison between engineering and other departments to ensure seamless communication and alignment on product development goals.
o Participate in strategic planning and product roadmap discussions.
o Collaborate with quality and regulatory teams to ensure all engineering activities comply with internal and external standards.
Process Improvements:
o Identify, develop, and implement best practices and continuous improvement initiatives within the engineering department.
o Optimize engineering workflows, tools, and methodologies to enhance efficiency, quality, and time-to-market.
o Drive initiatives to standardize processes where appropriate, while maintaining flexibility for custom projects.
The required qualifications for the job include:
o Bachelor s degree in engineering (e.g., Biomedical, Mechanical, Electrical, Software, Systems Engineering) or a related scientific discipline. Masters degree preferred.
o 10+ years of progressive experience in engineering roles within the life science, medical device, or biotechnology industry.
o 3+ years of experience in a leadership or management role, leading engineering teams.
o Strong understanding of product development lifecycle in a regulated environment (e.g., FDA 21 CFR Part 820, ISO 13485).
o Proven track record of successfully delivering complex engineering projects from concept to commercialization.
o Excellent leadership, communication (written and verbal), and interpersonal skills.
o Ability to manage multiple priorities and projects in a fast-paced environment.
o Strong problem-solving abilities and a strategic mindset.

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