R&D Engineering Manager- Disposables

Imricor Medical Systems Inc; Burnsville (MN); In loco; USD 140.000 - 180.000; Tempo pieno

Descrizione del lavoro

Imricor Medical Systems Inc in Burnsville, MN is hiring an R&D Engineering Manager-Disposables to lead the multidisciplinary development of catheter-based disposable devices and ensure compliance with the Quality System requirements and EH&S policies.

You will grow a cross-functional engineering team, work with capital equipment and software groups to integrate devices with platform systems, own design controls and V&V, and drive continuous improvement.

Competenze

• Bachelors degree in engineering or related field.
• 7-10 years engineering experience in medical devices.
• 1-3 years of management experience leading project teams of engineers and technicians.
• Experience with medical device design and product life cycle management.
• Experience with catheter-based or minimally invasive medical devices preferred.
• Demonstrated ability to identify and manage proficiencies and deficiencies in the department.
• Demonstrated ability to communicate priorities and decisions clearly and effectively.

Mansioni

• Owns the development of catheter-based disposable medical devices from concept through commercialization.
• Leads the design and development with design controls including planning, requirements definition, and traceability.
• Leads, hires, develops, and manages a cross-functional engineering team.
• Collaborates with capital equipment engineering and software engineering teams for integration.
• Develops engineering processes and procedures to support compliant product development.
• Partners with quality, regulatory, marketing to evaluate feasibility, cost, and customer needs.
• Drives development programs to meet milestones, quality standards, and V&V.
• Advises leadership on product changes affecting profit, schedule, cost, or client relationships.
• Drives continuous improvement and adoption of best practices in engineering design and testing.
• Stays current with industry trends and regulations to ensure innovation and competitiveness.
• Provides scheduling and budget input to R&D department strategy.

Conoscenze

Leadership

Design controls

Traceability

Cross-functional teamwork

Communication

Project management

Microsoft Office

Formazione

Bachelor's degree in engineering or related field

Strumenti

Microsoft Office

Descrizione del lavoro

Description

Supervisor’s Title: Director of Development Engineering
Exempt Status: Exempt

Location: Must be able to work at the Burnsville Location

Compensation: The expected salary/wage for this Minnesota-based position is between $140,000 -$180,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function

The R&D Engineering Manager-Disposables leads the multidisciplinary development of complex medical devices, including research, design, development, and evaluation of devices, equipment, and processes for catheter-based products that integrate with capital systems. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

• Owns the development of catheter-based disposable medical devices from concept through commercialization.
• Leads the design and development of disposable medical devices, ensuring robust execution of design controls including design planning, requirements definition, and traceability.
• Leads, hires, develops, and manages a cross-functional engineering team, fostering high performance, accountability, and professional growth.
• Collaborates with capital equipment engineering and software engineering teams to ensure successful integration of disposable devices with system-level platforms.
• Develops technical capabilities of the team to improve execution quality and efficiency.
• Develops and improves engineering processes and procedures to support efficient and compliant product development.
• Partners with cross-functional teams (e.g., quality, regulatory, marketing) to evaluate technical feasibility, cost, and customer needs for catheter-based products.
• Drives execution of development programs to meet key milestones, quality standards, and program objectives, including successful completion of verification and validation activities.
• Advises leadership and other stakeholders on product or design changes that may affect profit, schedule, cost, or client relationships.
• Drives continuous improvement and adoption of best practices in engineering design, documentation, testing, and validation
• Stays current with industry trends, technologies, and regulations to ensure innovation and competitiveness.
• Provides scheduling and budgetary input to overall Research and Development department strategy.
• Other relevant duties as assigned.

Requirements

Qualifications

• Bachelors degree in engineering or related field.
• 7-10 years engineering experience preferred in the medical device industry.
• 1-3 years of management experience leading project teams of engineers and technicians.
• Experience with medical device design and product life cycle management.
• Experience with catheter-based or minimally invasive medical devices preferred.
• Demonstrated ability to identify and manage proficiencies and deficiencies in the department (e.g. skills, resources, etc.).
• Demonstrated ability to communicate priorities and decisions clearly and effectively.
• Experience with Microsoft Office: Word, Excel, PowerPoint.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
• Requires fingering, repetitive motion, talking and hearing.
• Requires significant viewing and working at computer a screen.
• Significant work pace & pressure due to deadlines.