New Product Introduction (NPI) and Engineering Manager

This job is for an energetic ambitious individual to work on very rewarding projects with a team of excellent people and professionals.

This position requires work in California and Massachusetts with frequent travel within the USA.

This position requires work with Multiple Time Zones.

If the above is not your calling, please don't apply.

Dynamic, High-Impact Role with Global Reach

Are you an experienced professional with a passion for driving success and making a tangible impact?

At Resolvem Inc., we are looking for a dedicated and motivated individual to take on a dynamic role that offers both challenge and opportunity. This position offers the chance to work with cutting-edge medical device companies, lead impactful projects, and work directly with a diverse team across multiple time zones. With up to 50% travel, this role requires someone who thrives in a fast-paced, global environment, enjoys problem-solving, and is committed to ensuring our customers’ success. If you have the drive to grow within a forward-thinking company and are excited about contributing to the future of medical device manufacturing, we want to hear from you!

About Resolvem Inc.

Resolvem Inc. is an engineering services company specializing in transferring product designs to design control and manufacturing. We work with companies that develop medical devices, helping them bring their designs under design control, prepare them for mass manufacturing, and support their pilot manufacturing and transition to commercial-scale production.

We focus on the details so our customers can concentrate on the big picture—driving key design improvements and meeting customer needs.

Resolvem’s clients vary in terms of in-house manufacturing capabilities, but they rely on custom components and assemblies from contract manufacturers to meet their production needs.

Position overview

We are seeking a highly skilled and detail-oriented individual to help set up new product introduction (to manufacturing) of capital equipment products. In this role, you will act as the liaison between our distributed design and engineering teams and our customers’ contract manufacturers, ensuring smooth operations across all phases of the manufacturing process.

You will be responsible for managing the day-to-day operations of contract manufacturing facilities, including planning, coordinating, and directing the activities that result in finished products. This role encompasses overseeing manufacturing, work scheduling, tracking timely orders and supply of product Bill of Material, creating and adhering to work procedures, and maintaining quality control.

In addition, you will play a key role in establishing process improvements, managing the supply chain, and optimizing the value stream for both existing products and next-generation designs.

Responsibilities

Manufacturing Operations:

• Build and track BOM and configurations/revisions in collaboration with R&D engineers.
• Oversee the manufacturing process and ensure products meet quality and production goals.
• Plan and optimize the use of contract manufacturing suppliers and equipment.
• Manage production schedules and ensure timely delivery of finished goods.
• Participate in pilot assembly and generate assembly procedures and documentation.
• Create rework instructions for components and assemblies to modify non-conforming parts or update parts due to design changes.

Liaison and Communication:

• Act as the primary point of contact between R&D teams and contract manufacturers.
• Coordinate personnel, test equipment, and instruments to fulfill the production build plan.
• Effectively communicate project status, timelines, and critical issues to all levels of the organization.

Supply Chain and Inventory Management

• Maintain accurate product BOM (Bill of Materials).
• Lead procurement activities, including sending out requests for quotes, recommending suppliers, and routing purchase requests for approval.
• Manage inventory control at both Resolvem’s customer site and the contract manufacturer’s site, ensuring adequate stock levels and timely communication with management.
• Identify and pursue opportunities for outsourcing or adding new suppliers to improve the value stream.

Process and Quality Management

• Ensure contract manufacturing complies with all material and part traceability requirements.
• Drive continuous improvement efforts to enhance manufacturing efficiency and product quality.
• Advise the R&D team on future designs to improve manufacturability and reduce production costs.
• Develop and implement standard operating procedures (SOPs), revise manufacturing documentation, and process documents.
• Oversee PFMEA (Process Failure Mode Effects Analysis) and process validation activities when required.
• Advise the leadership team on quality risks, initiate reports for deviations or non-conforming materials, and recommend corrective and preventive actions (CAPA).

Team Development

• Build and manage a successful production operations team for Resolvem’s customers, ensuring necessary staffing, competence, and tooling to meet production targets.

Education

· Bachelor’s degree in business, manufacturing, or engineering is preferred

Required Experience

• 5 years of experience in supply or production management within a Medical Device manufacturing environment.
• Experience in New Product Introduction of capital equipment.
• Experience with electromechanical assemblies is a plus.
• Field service engineering/support experience is a plus.

Knowledge, Skills, and Abilities

• Experience with continuous improvement processes (e.g., Lean, Six Sigma).
• Strong communication and organizational skills.
• Ability to collaborate effectively with individuals at all levels of the organization, both remotely or face to face.
• In-depth knowledge of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) requirements.
• Proven ability to lead and manage a diverse manufacturing team.
• Attention to details.
• Strong understanding of medical device manufacturing processes, including NCRs (Non-Conformance Reports), CAPAs, PFMEA, GDP, RMAs (Returned Material Authorizations), rework processes, DHRs (Device History Records), and Supplier Management.

Other Duties/Standards:

The job is a hybrid job with limited supervision as part of a team that is distributed in multiple location.

The job may require up to 50% travel to customers’ sites and contract manufacturing sites.

The job requires work with multiple time zones around the world.

The above descriptions are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Resolvem Inc. utilizes the multi-skill concept and expects the employee to perform other job disciplines. Resolvem Inc. retains the discretion to add or change the functions and duties of the position at any time.