Director, R&D Engineering

Getinge•Merrimack, NH

About The Position

The Director of Product Engineering manages the Design Maintenance process and sustaining engineering activities for implantable and consumables products to meet business needs. Responsibilities include developing and directing teams to implement design and process changes to support all commercially released devices. This position requires oversight of Engineering Managers who lead teams to support CAPAs, NCRs, Product Complaints, supplier changes, cost reduction initiatives and compliance projects. The role requires frequent and coordinated interaction with Merrimack site Management, New Product Development, Product Management, and Operations stakeholders.

Requirements

Bachelor's degree in any discipline
10 years of experience in medical device product development, design transfer, product launch, Engineering support, and design maintenance.
Strong working knowledge of Design Control requirements: 21 CFR820 and ISO13485
Exceptional analytical skills and effective decision-making skills.
Understanding of mechanical design, material science, and process design.
Intermediate knowledge of Usability Engineering and Packaging Engineering.
Solid working knowledge of balloon catheters, arterial stents, vascular graft technologies, and drainage products.
Ability to question existing practices and identify new ways of working.
Strong interpersonal relationship skills.
Ability to understand, resolve, and communicate complex technical and business information.
Ability to develop and mentor senior staff.
Strong knowledge of design inputs/outputs, verification, validation, usability, and packaging requirements.
Understanding of department and project budgeting and accounting principles.
Supervision of 4-6 direct reports and ~30 indirect reports.
Full accountability to hire, fire, or discipline team members.
Interfaces with device users, suppliers, and contract development organizations.
Develops and maintains strong relationships with internal functions.
Ensures environmental consciousness and safe practices.
Use of computer, phone, and office equipment.
May work extended hours.
Travel up to 15%.
Build quality into all work by maintaining compliance to quality requirements. Ensure compliance to FDA and worldwide quality regulations. Attend required training. Adopt the "Beyond Compliance Quality Culture."
Each organization shall establish appropriate authority and interrelation of employees who manage, perform, and assess work affecting quality.

Responsibilities

Develop and manage Design Maintenance Processes to bring solutions to our external customers and meet customer needs (~10%)
Manage the effective execution of product development projects through Design Control Quality Plans (DCQPs) and Supplier Change Assessment Plans (SCAPs) (~30%)
Support Corrective and Preventive Action staffing and subject matter expertise needs through all phases of CAPA (~30%)
Develop group and staff capabilities through direct reporting management (~15%)
Develop continuously improving strategies to execute design maintenance projects (~10%)