SetPoint Medical’s Supply Chain Project Manager is responsible for projects and activities related to supply chain management, including purchasing, tracking budget expenses, supporting vendor relationships, documentation, and production planning. This motivated and self-driven project manager will ensure timely execution of supply chain relevant projects, as well as ensuring product compliance per the SetPoint Quality Management System. The Supply Chain Project Manager will be well versed in Class III medical device manufacturing processes and controls. 

All candidates must be self-motivated, independent, and able to work efficiently in a small team environment. A successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project and organization priorities. As SetPoint works exclusively through contract manufacturers, it is essential that the Supply Chain Project Manager has excellent communication skills. This position will report to the Director of Program Management.

This position is in office, Monday - Friday, reporting to company headquarters in Valencia, CA. A hybrid schedule is negotiable after 90 days of employment. Relocation assistance is not available.

Job Responsibilities

Responsibilities will vary depending on the Supply Chain Project Manager’s skillset, but may include: 

• Identify and manage project scope and communicate changes in scope to management team.
• Create short term and long term plans and identify resource requirements.
• Assemble and coordinate project timelines directly with teams from Product Development, Quality Assurance, Clinical Affairs, Operations, Regulatory Affairs and Marketing. 
• Plan, schedule and ensure adherence to project deadlines.
• Identify, mitigate and manage project risks.
• Ensure adherence to design control operating procedures.
• Plan and prioritize manufacturing processes to ensure component and device availability.
• Maintain accurate detailed reporting to ensure agreed upon production schedules and budgets are being achieved.
• Maintain assembly and product level cost of goods (COGs).
• Prepare semi-annual supplier reports, including forecast, key performance indicators (KPIs), and yield rates.
• Support development, deployment, execution, and compliance of supplier/supply agreements.
• Maintain contractual records to coverage and compliance.
• Coordinate supplier workflow for one or multiple products. 
• Work with Manufacturing to determine equipment and raw materials needed to cover production demand. 
• Obtain output of information (number of finished products, percentage of defective, etc.).
• Support supplier management and supplier quality initiatives.
• Prepare quarterly supplier and manufacturing forecasts.
• Support SetPoint Medical Operations activities as required.

Skills and Abilities

• Work collaboratively on cross functional teams, including with customers and suppliers, to establish detailed and accurate schedules.
• Attention to detail.
• Excellent written and oral communication skills
• Analytical mindset: ability to analyze and present data; ability to do basic research and present results.
• Strong leadership, organizational and time management skills

Minimum Qualifications

• BA, BS, or a minimum of 5 years of Project Management and/or Purchasing, Supply Chain, or Procurement experience in a regulated environment.
• Strong project management experience with knowledge of production planning and quality control principles.
• Experience in Manufacturing Resource Planning (MRP).
• Working knowledge of MS Office and ERP systems; ability to create data analysis tools and spreadsheets to manage data.

Preferred Qualifications

• Medical device industry experience of 5 or more years is highly desirable.
• Strong motivational skills including the ability to influence across all levels of the organization.
• Contract negotiation skills at a senior level; drive performance metrics/KPI’s in accordance with business strategies and goals
• Ability to read and interpret product drawings and specifications

Location

• Company Headquarters in Valencia, CA.
• This position will travel up to 10 percent.

Company Description

SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases with its neuroimmune modulation platform.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.