Manufacturing Quality Engineer

InkSpace Imaging develops and manufactures Magnetic Resonance Imaging (MRI) coils focused on improving the patient experience. Our company takes advantage of cutting-edge technologies in printed electronics and medical device design to make getting an MRI easier for patients. Our coils are ultra-light weight and contour the body for maximum image quality and fast set-up times. Come join an exciting start-up disrupting the MRI market! 

The Manufacturing Quality Engineer will be responsible for combining manufacturing expertise, critical thinking, medical device quality engineering skills, and innovative problem-solving approaches to support manufacturing of our MRI coils. 

Responsibilities:

·       Improve MRI coil manufacturing processes for PCBA and mechanical assembly.

·       Develop and sustain manufacturing processes in No-code Platform.

·       Lead Defect, CAPA, NCMR, FMEA, and Change Management activities.

·       Perform quality assessments as required by the QMS.

·       Participate in design reviews and provide expert technical Quality input to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/ resources/ budget.

·       Author, review and approval of manufacturing documentation (e.g., for the product design history file).

·       Provide expert Quality input for proposed design and/or process changes. This includes ongoing identification of potential areas of improvement to improve the efficiency and outputs of processes related to products.

·       Supplier Quality:

·       Author quality agreements, advise on and support the effective quality management of third parties and external manufacturers.

·       Ensure adequate supplier control plans are implemented, documented, and maintained.

·       Oversee supplier monitoring activities, and support supplier changes.

·       Conducts internal and supplier audits.

·       Contributes to Reporting and Management Reviews.

Required Education/Qualifications:

·       Bachelor’s degree or equivalent in Electrical, Mechanical, or Materials engineering, quality-related field or equivalent combination of education, training, and experience

·       Minimum:

·       2 years in medical device industry, including experience focused on quality engineering related activities 

·       Working knowledge of relevant international ISO/IEC Standards (13485, 14971), regulations (2017/745 European Medical Device Regulation (MDR) s, 21 CFR - Part 820), and guidance.

·       Printed circuit board assembly experience

·       RF experience is preferred.

·       Strong interpersonal, influencing, analytical, and problem-solving skills with demonstrated ability to collaborate effectively across a variety of internal/external stakeholders in demanding/ changing situations (medical, scientific, and production) to build trust, confidence, and collaboration toward shared objectives.

·       Strong communication skills, with ability to get points across clearly and simply to all levels of the organization

InkSpace Imaging offers a terrific work environment, professional development, and competitive compensation with stock options. The base pay range for this role is between $68,000 and $90,600, and your base pay will depend on your skills, qualifications, and experience. This role is on-site and based in Pleasanton, CA.

We are an Equal Opportunity Employer. Our employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

InkSpace Imaging only employs those legally authorized to work in the United States. Any offer of employment is conditioned upon the successful completion of a drug screen, past employment verification, and other applicable tests as required for the position. Unless expressly stated, relocation assistance is not provided.