Design Assurance Program Manager:
Any applicant must have an existing work permit Stamp 4 or an EU passport to apply.
The Program Manager provides design assurance engineering leadership and will fulfill the role of Quality Core Team Member (QCTM) on key programs in new product development for Coronary and Renal Denervation products. This includes managing extended team representing the following sub functions within QA:
DAE, Mfg. QE, Component Engineering, Receiving Inspection, Sterilization/ Microbiology, PxM, Supplier Quality Engineering, Configuration Management, Test Labs. Work is accomplished through matrixed employees/teams who are not direct reports but for which the incumbent has direct accountability to lead and achieve program objectives.
• Represent, lead, and is accountable for the functional group on the Core Team and is an integral participant in the planning and execution of the project(s).
• Can process requirements from multiple quality sub-function stakeholders and represent in decision making process.
• Project-manage functional tasks and deliverables per the project plan.
• Proactively identify and manage project dependencies and risks.
• Helps establish program objectives, timelines, milestones, and budgets.
• Provide input to functional manager on extended team member performance and development.
• Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
• Identify and manage risk using a FMECA and/or other risk management tools.
• Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
• Establish verification and validation strategies with R&D and Regulatory to assure an efficient approval path.
• Develop master test plans that encompass design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectives.
• Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with designs.
• Interface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globally.
KEY SKILLS & EXPERIENCE
• Qualified person to Bachelor/Master’s Degree level 8 in Mechanical, Biomedical or related engineering discipline and with a minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
• Dynamic team player and can work effectively and proactively on cross-functional teams.
• Collaborate across organizational boundaries and take appropriate actions when problems occur.
• You are an experienced professional in engineering development with extensive engineering knowledge and skills in some or all of the following: risk management, component and system design, materials (polymers and metals), sterilization of medical devices, test method development, design for six sigma principles, pre-clinical evaluations, physician interactions, knowledge of anatomical use conditions (anatomy, physiology etc.), system requirements development, design control, application of ISO standards for medical devices.
• You are a good communicator and fluent in English, both in writing and speaking
• High level of enthusiasm and motivation, and the ability to take input from others are desirable.
• Understanding of mechanical-electrical medical systems, products, and therapies.