Position Summary:
The Staff Engineer will drive project execution, product changes, compliance and process improvements associated within the on-market portfolio. The Staff Engineer will have the opportunity to lead and drive new product introduction for NPI project/ program. Both roles will work with members from various functions (Product Marketing, Platform Management Teams, Development, Operations, Supply Chain, Quality and Customer Support etc.) to improve manufacturability, quality and customer satisfaction for on-market products. This role must be able to work independently, handle multiple projects in parallel, and communicate effectively across all levels of the organization.
Position Responsibilities:
- Full ownership and accountability for the assigned on-market platforms. Support Platform Management Teams (PMTs) on associated projects and investigations.
- Full ownership and accountability for the assigned NPI project/ program.
- In NPI project/ program, represent Instrument Operations, Singapore to support NPI core team to deliver successful new product launch.
- Lead Product Development Process (PDP) process within Instrument Operations by early involvement in NPI with Product Development team to transfer technology and knowledge into operations.
- Responsible for the success of on-market platforms end-to-end, from incoming materials, manufacturing performance and processes, field performance and escalations, cost savings, continuous improvements, parts obsolescence management, etc., supported by assigned engineering resources.
- Lead and drive continuous improvement initiatives, engineering changes and implementation for assigned on-market platforms.
- Partner with Field Management team to coordinate field actions, drive complaint investigations and escalations, with corrective and preventive action implementations.
- Lead project planning activities by developing project plan, scope definition, key tasks, milestones, dependencies, and critical paths.
- Engage cross-functional teams to determine project risks and develop mitigation plans.
- Responsible for all project timelines and deliverables with budget and resource management as required.
- Track and report on project success KPIs.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
- 5 years experience in managing projects within operations or product development.
- Understand product development lifecycles and on-market management of products.
- Experience working in cross-functional teams comprising of various internal organizations.
- Strong leadership with ability to influence across the organization at all levels.
- Strong problem solving and analytical skills, ability to solve complex and diverse business problems.
- Ability to work in a highly collaborative and fast-paced environment.
- Ability to work independently and collaboratively across disciplines required.
- A self-organized, self-starter, highly motivated individual capable of multi-tasking.
- Effective and strong communication skills – both written and verbal. Able to articulate and discuss ideas and persuade others to achieve common outcomes.
- Experience working in a regulated environment and familiar with Design Controls for the development of medical devices such as 21CFR820, ISO 13485, and ISO 14971.
- Able to identify components with different colors (using visual)
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
- Bachelor’s degree or equivalent in Engineering required. Graduate degree is preferred.
- 10+ years of working experience with 5-7 years of relevant experience in product development, product life-cycle management, and project management in a regulated industry.
