
Medical Device Project Lead
2 weeks ago
Job Description:
\We are seeking a seasoned Project Manager to lead our medical device projects. The ideal candidate will have extensive experience in project management, with a proven track record of delivering results on time, within scope, and within budget.
\Key Responsibilities:
\- Provide project management leadership to R&D-led medical device projects\
- Lead cross-functional teams to deliver projects on time and within budget\
- Foster collaboration with various functions, including Operations, Supply Chain, QA, RA, Clinical, and Marketing\
- Gather requirements and develop comprehensive project management plans\
- Delegate project workstreams and tasks effectively and hold team members accountable\
- Monitor and control projects, deliver milestones on time, within scope, and within budget\
- Report progress and variance to plan with transparency to management and governance as required
Requirements:
\To be successful in this role, you will need:
\- A minimum of 5 years industrial experience in project management in medical devices marketed under ISO Class III or Class IIb implantable medical devices preferred\
- Proven experience taking accountability for projects with successful goal achievement history, including under Design Control\
- Experience leading or participating in Agile/Hybrid project teams preferred\
- Experience in Six Sigma methodologies, e.g., Lean or DFSS\
- Demonstrated experience engaging with senior management\
- Involved in change control for manufacturing process and suppliers\
- Experience with successfully supporting global regulatory submissions and amendments\
- Proven experience working with contracted vendors and labs is a plus
Skills/Accreditations:
\You will be a strong fit for this role if you possess the following skills:
\- Ability to think critically and innovatively combine willingness to challenge status quo\
- Excellent standard of work delivery and technical documentation skills, incorporating Good Documentation Practices\
- Excellent communication and presentation skills, both verbal and written\
- Ability to engage, negotiate, and influence senior managers and stakeholders across discipline, function, and geographical boundaries\
- Detail-oriented and ability to make decisions based on facts\
- Self-starter with excellent organizational skills\
- Self-awareness and good work ethics
Academic Qualifications:
\A Bachelor's degree in science or engineering or a relevant field is preferred, along with Project Management certification (e.g., PMP) and Six Sigma certification.
\Travel Requirements:
\Up to 20% travel may be required, typically within Asia, but may need to travel to Europe or the USA.
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