Responsible for investigating and providing microbiological guidance across product development, design transfer, and manufacturing processes, overseeing the Microbiology Technician and ensuring compliance with regulatory and quality standards.
Responsibilities
Support product development projects and design transfer efforts
Support the Regulatory Affairs department in registry and renewal of existing registrations
Coordinate requalification of critical systems such as HVAC and compressed air
Coordinate viable and nonviable monitoring of the clean room and product
Lead efforts to address nonconformities and out-of-specification results
Requirements
Bachelor’s degree in Microbiology or Biotechnology Engineering
Lead new product introduction engineering for medical device orthodontic products, ensuring compliance with regulatory and quality standards.
Compensation
$115,400 - $141,000
Responsibilities
Collaborate with R&D, QA, Regulatory Affairs, Manufacturing, Supply Chain, and Product Management teams
Support product teams through Phase-Gate development activities and deliverables
Participate in Design Control activities including planning, reviews, risk management, verification, validation, design transfer, and change management
Assist project teams in meeting internal quality system and regulatory requirements
Develop, execute, and document engineering studies, test methods, protocols, and technical reports
Requirements
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related Engineering disciplines
Nice to have: Understanding of EU MDR requirements
Nice to have: Familiarity with FDA, EU MDR, ISO 13485, ISO 14971
Nice to have: Experience with electro-mechanical integration
Lead engineering program management for complex precision electromechanical systems in R&D, coordinating multidisciplinary teams from lab setup to production ramp-up.
Compensation
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 84,880.00 EUR - 127,320.00 EUR
Responsibilities
Own and drive selected engineering workstreams from definition through delivery
Drive day-to-day execution by following up on commitments, removing blockers
Maintain integrated execution picture across workstreams
Establish and lead effective operating rhythms
Identify cross-workstream gaps and coordinate stakeholders
Requirements
Engineering degree or comparable technical qualification
Master's degree
Nice to have: medical-device experience
Nice to have: formal program/project-management training
Lead and manage multi-site, multi-process programs in the medical device manufacturing sector, ensuring alignment with strategic objectives, budget, and schedule.
Compensation
The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $96,000.00- $155,000.00.
Responsibilities
Oversee the planning, execution, and completion of Operations programs
Keep projects on track and ensure timely completion within scope
Coordinate cross-functional teams across multiple sites
Delegate and manage tasks among team members
Manage stakeholder communication and provide regular updates
Requirements
Bachelor’s degree in engineering or related technical discipline
Nice to have: medical products industry experience
Nice to have: Contract Manufacturing experience
Nice to have: ISO 13485 certified facility expansion and relocation projects
Technical and Program Lead for R&D, focusing on opportunity identification, technical leadership, and cross-functional program management in medical device development.
Locations (2)
Singapore, Singapore
Tuas, Singapore
Responsibilities
Work with Commercial and Marketing teams to find unmet clinical and customer needs and turn them into product concepts.
Apply financial and business case fundamentals (NPV, IRR, ROI, COGS, and P&L) to inform R&D priorities.
Find, set up and manage external development partners including suppliers, design houses, and KOLs.
Act as technical lead on assigned projects, setting technical direction and leading feasibility assessments.
Lead technical de-risking by identifying, characterizing, mitigating, and retiring risks.
Act as the primary point of contact for clients, managing projects and leading multidisciplinary development teams to ensure technical success from concept to manufacturing launch for medical devices.
Responsibilities
Lead medical device projects through design controls, including user needs, design inputs, risk management, design reviews, verification and validation, and design transfer to manufacturing.
Lead multiple simultaneous projects and/or large complex multi-disciplinary projects with the equivalent of >3 FTE contributors and/or external partners and consulting sales of >$750k per year.
Lead the creation, planning, and reporting of project scope, timelines, financial management and performance.
Collaborate with regulatory, clinical, and quality experts to align development plans with the target regulatory pathway (e.g., FDA 510(k) or De Novo, Health Canada, EU MDR).
Lead client meetings and all client communications including non-technical aspects such as billing, expenses, etc.
Requirements
university degree in a relevant engineering discipline (i.e., Biomedical/Mechanical, Electrical, Mechatronics)
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