Staff Engineer, R&D - Technical/ Program Lead

What You'll Do

Opportunity Identification & Project Initiation

• Work with Commercial and Marketing teams across multiple businesses to find unmet clinical and customer needs, then turn them into product concepts and project proposals.
• Apply sound understanding of financial and business case fundamentals, including NPV, IRR, ROI, COGS, and P&L impact, to inform R&D priorities, development trade-offs, and phase-gate decisions
• Assess competitive products, technology trends and partnership opportunities that could affect the regional portfolio.
• Find, set up and manage external development partners, including suppliers, design houses, key opinion leaders (KOLs) and academic institutions.

Technical Leadership

• Act as the technical lead on assigned projects. Set technical direction, lead feasibility and risk assessments, and dig into complex engineering problems when needed.
• Lead technical de-risking: identify, characterize, mitigate and formally retire risks with objective evidence.
• Oversee system integration, design verification and validation, and design transfer to manufacturing.
• Apply Design for Six Sigma (DFSS), Design to Cost and Design for Manufacturability methods to meet project goals.

Program & Project Leadership

• Lead cross-functional core teams through BD's phase-gate product development process, from concept to launch and post-launch.
• Own project plans, work breakdown structures, integrated timelines and resource plans. Manage several projects across businesses at the same time.
• Own project budgets and contribute to regional R&D financial planning.
• Give senior leadership clear, regular updates on progress, risks and decisions needed.

People Leadership & Influence

• Lead and motivate cross-functional, multi-site teams through influence and technical credibility.
• Mentor engineers and give them technical direction and feedback.
• Take on direct people-management responsibility as the team grows.
• Build trusted relationships with business leaders, Worldwide R&D, functional partners and senior external stakeholders.

Quality & Compliance

• Make sure design and development work follows ISO 13485, FDA QSR and BD's Global Product Development System (GPDS), including Design History File documentation.

About You

Required

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or a related engineering field.
• 8+ years of product development experience in medical devices or another regulated industry.
• Proven track record of taking products from concept to launch under a phase-gate process.
• At least 3 years leading cross-functional projects or core teams.
• Broad technical knowledge across device design, systems integration, risk management (FMEA), verification and validation, and design transfer.
• Working knowledge of financial and commercial drivers such as ASP, COGS, gross profit, NPV and ROI, with experience building business cases and managing project budgets.
• Experience working with commercial or marketing teams on opportunity identification or product definition.
• Strong communication, presentation and influencing skills with audiences from engineers to senior executives.
• Able to manage ambiguity, set priorities across multiple businesses, and make decisions with limited information.
• Experience working in a matrix, multi-site and multi-time-zone organization.

Preferred

• Master's degree in engineering or a related field.
• Experience with developing electromechanical medical device
• Experience mentoring or supervising engineers.
• Professional proficiency in another Asian language, such as Japanese and Mandarin, isa strong advantage.
• Understanding of clinical settings and of how healthcare works in Asian markets.
• PMP, DFSS or Six Sigma Green/Black Belt certification.

Travel: about 25%