Sr. Manager New Product Introduction

New employees are eligible for the following benefits effective date of hire!

• 401k Plan with Company Match
• Company-paid life insurance and disability benefits
• Tuition Reimbursement
• Self-managed (unlimited!) PTO and 11 paid holidays
• Medical, dental, and vision benefits

Company Overview

Meraqi Medical , now a part of Viant Medical, provides design, development, and manufacturing services to medical device companies in the bioelectronics, interventional and structural heart, and minimally invasive surgical spaces. Meraqi provides solutions from early brainstorming, conceptualizing and prototyping, to full design and development, as well as clinical and commercial manufacturing.

Viant Medical is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn .

Position Summary

Directs the New Product Introduction (NPI) process from concept through verification/validation and into market introduction via low-volume commercial manufacturing on a contract basis for client companies by providing Product Development, Quality, or Operations expertise. The NPI Program Manager has direct applied experience and demonstrated proficiency in at least two of the three disciplines. The individual will possess a broad range of medical device design and development skills and experience.

Essential Duties And Responsibilities

• Organizes interdepartmental activities ensuring completion of the project on schedule and within budget constraints in order to deliver the business solution to the customer.
• Leads efforts to analyze current project operations, makes recommendations for improvement and coordinates the decision making process.
• Provide Quality input to Product Development team. Contribute to product quality assurance from NPI and eventual transition to ultimate manufacturer.
• Writes and reviews customer proposals.
• Conducts feasibility studies of the design to determine ability to function as intended.
• Provide Product Development design input to Product Development team.
• Interacts with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information.
• Conducts risk analysis for products under development.
• Responsible for establishing and developing cross-functional teams to support NPI process and may identify optimal opportunities for product.
• Prepares during the proposal phase and maintains during the program, project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs and risks plus containments/mitigations.
• Provide Operations design input to Product Development team.
• Responsible for delivering the business solution to the customer’s problem.
• Any other duties as assigned.
• Maintains detailed documentation throughout all phases of research and development, NPI transition to clinical/commercial manufacture, and transfer to ultimate manufacturer.
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Establish robust assembly processes for products developed by or transferred into Vention.
• Ensures all work satisfies the requirements of the company’s Quality Manual.
• Manages the resources of the various departments to ensure that staff is appropriately loaded to meet program requirements.
• Facilitates information flow among team members, the project leader, finance, senior management and the corporate client.

Required Education, Experience, Skills And Knowledge

• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
• Depth of knowledge in one or more clinical areas.
• Ability to interact with client companies in a professional manner.
• Past experience in medical device Quality, Development, Manufacturing and/or Program Management and/or Project Leadership required.
• Proficient using a complete variety of office equipment and laboratory machinery and tools and/or training others.
• Demonstrated ability to successfully bring products from concept to commercial manufacture.
• Depth of knowledge in one or more product areas.
• Knowledge of Six Sigma methodology.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• Tolerant of exposure to chemicals found in medical device R&D laboratory environment.
• Depth of knowledge in one or more technical areas.
• Bachelor's degree in Mechanical or Biomedical Engineering is desired, Master’s degree preferred.

PAY RANGE

We offer market competitive compensation. Potential salary range for this role is $150,000-$180,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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