Sr Manufacturing Engineer - Capital Equipment

Telos Health; Campbell (CA); On-site; USD 121,000 - 133,000; Full time

Benefits offered by this job

Stock Options

401k Plan

Health Benefits

Generous PTO

Parental Leave Program

Emotional Health Resources

Job summary

An innovative medical equipment manufacturer is seeking a Senior Manufacturing Engineer to join their Campbell, California team. This role is pivotal in ensuring that manufacturing processes meet stringent quality and regulatory standards, directly impacting patient care. You will be responsible for developing manufacturing processes, collaborating with R&D, and leading continuous improvement initiatives. If you're passionate about engineering and want to make a difference in healthcare, this is the perfect opportunity to advance your career in a supportive and dynamic environment.

Qualifications

• 5+ years of experience in manufacturing engineering in a regulated environment.
• Strong knowledge of FDA and ISO regulations.

Responsibilities

• Manage manufacturing processes and ensure compliance with quality standards.
• Collaborate with R&D for smooth product transitions into manufacturing.

Skills

Project Management

Excellent Communication Skills

Independent and Team Work

Continuous Improvement Techniques

Education

Bachelor's Degree in Engineering

Tools

GMP

GDP

FDA QSR

ISO 13485

Job description

Sr Manufacturing Engineer - Capital Equipment

Job Title: Senior Manufacturing Engineer – Capital Equipment

Location: This position is based in our Campbell, California offices. This position is on-site and full-time with some travel.

Why Imperative Care?

Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do

• Execute in-house and/or contract manufacturing activities and build relationships that ensure products are manufactured adhering to plans and quality/regulatory requirements.
• Work with Supply Chain to ensure inventory of raw materials and components are available per planned build schedule, lead and be accountable for material issued to production/projects.
• Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality.
• Create construction prototypes for new products/processes or current product enhancements.
• Perform time studies for each manufacturing process and identify process development initiatives.
• Work with Quality personnel to define in-process inspections, test and resolve quality/yield issues through continuous improvement projects.
• Contribute to multi-functional operations project team activities from early project conceptualization through clinical testing, creating, maintaining, and executing manufacturing tasks related to project schedule ensuring critical timelines and budgets are established and met.
• Participate in manufacturing team meetings to facilitate communication between members.
• Establish positive, proactive working relationships with team members and other staff members.
• Develop manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
• Determine tooling and equipment needs for the timely and cost-effective manufacture of products.
• Collaborate with R&D to ensure smooth transition of products into manufacturing, achieving cost targets, assuring manufacturability and conformance with regulatory and company requirements.
• Work with suppliers to ensure parts/services are properly documented and meet specifications.
• Procure specifications for sub/final assemblies including design, document and tooling verification.
• Establish manufacturing line and approve DCO’s for manufacturing engineering.
• Train/Certify MPI Trainer for manufacturing process instructions; may train other staff as needed.
• Use continuous improvement techniques, and work with Quality Assurance to identify and implement programs to drive costs down and improve yield and reliability.
• Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is cost effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company’s Quality System requirements.

What You’ll Bring

• Bachelor’s degree in engineering, or related discipline and a minimum of 5+ years of related experience; or equivalent combination of education and work experience.
• Demonstrated knowledge and experience in pilot/production line set up and validation in controlled environment, including work under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
• Ability to detail project plans effectively.
• Familiar with GMP, GDP procedures and requirements.
• Excellent communications skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Project management experience preferred.
• Must be able to travel.

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Salary Range: $121,000 - 133,000 annually

Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.

Join Us! Imperative Care

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Engineering and Information Technology

Industries: Medical Equipment Manufacturing