- definition of product requirements and implementation of supplier controls for contract manufacturers
- understanding of key process parameters, manufacturing techniques, assembly processes and equipment and systems testing requirements
- knowledge of contract manufacturing and supply chain with emphasis on electronics and capital equipment manufacturing
- ability to develop and communicate a forecast across the entire supply chain
- knowledge and fluency of medical device design controls, software development life cycle, medical device quality management systems, all supporting domestic and international standards and regulatory requirements (e.g. 21CFR820.30 and 21CFR11, EU Regulation 2017/745 Medical Device Regulation, ISO14971, IEC60601-1, and IEC62304)
- excellent written and verbal communication skills necessary to effectively communicate to Management project status, issues, development risks and mitigations, various development activities
- strong organizational skills and attention to detail
- understanding of ERP systems and requirements related to medical devices including experience with ERP system implementation
- proven track record of managing relationships and activities with key suppliers and contract manufacturing partners
- ability to adapt quickly in a fast-paced, evolving company, and operate with a high sense of urgency
- excellent interpersonal and collaborative skills to develop a team with the same skills
- As a seasoned technical expert with a proven leadership track record, lead and manage the development of a world class supply chain for the Companys line of innovative therapies.
- Collaborate closely with Research and Development to support next-generation product development.
- Coordinate engineering sustaining activities and supplier change requests for capital equipment with Research and Development, Quality, and Regulatory to ensure continuous product availability.
- Establish strategic material planning with contract manufacturers to ensure product delivery through entire product lifecycle from new product introduction to obsolescence. Provide insight on new technologies, materials and manufacturing techniques that will drive innovation and patient outcomes.
- Support Finance for product costing, invoicing, and cash flow tracking.
- Provide insight on new technologies, materials and manufacturing techniques that will drive innovation and patient outcomes.
- Work with the Sales and Marketing Team to determine capacity, forecast and order planning to ensure continuous product availability worldwide.
- Keep abreast of global electronic supply trends, technologies and key suppliers.
- Provide thorough oversight of manufacturing documentation with the goal of supporting a manufacturing process fully compliant with the Galvanize Quality Management System (QMS), applicable standards and guidance (e.g. IEC62304).
- Provide Regulatory Affairs with technical input and concise documentation in support of regulatory submissions.
- Medical, Dental, Vision, Life Insurance, LTD/STD
- 100% company paid medical coverage for employees
- Flexible Paid Time Off
- Paid Parental Leave
- Company sponsored 401(k)
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Supply Chain Manager, Electrical and Capital Equipment - Redwood City, United States - Galvanize Therapeutics, Inc.
Description
Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.
General Description
The Supply Chain Manager, Electrical and Capital Equipment, is responsible for the complete supply chain for capital equipment that supports the Companys world-class therapies. The Supply Manager will work heavily with Research and Development on new product concepts and development, provide leadership in determining manufacturing technologies and suppliers for new and existing product lines, and manage the overall capital equipment supply chain, including ongoing engineering activities.
Key Requirements:
Education and Training
Engineering degree in Mechanical, Electrical or Manufacturing, with consideration given to a degree level combined with experience. Other degrees within the engineering discipline acceptable with applicable medical device experience.
Skills and Experience
Technical expert in medical device capital equipment design and manufacturing that includes technical development experience with the following:
Other
Some domestic and international travel required to collaborate with contract manufacturers and suppliers.
Key Responsibilities
What Galvanize Offers
This role pays between $140,000 and $160,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.
Due to the nature of our business and the role, please note that Galvanize Therapeutics may require that you show current proof of vaccination against certain diseases including COVID-19.
Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
