Principal Manufacturing Engineer at Qapel Medical LLC – Fremont, California

Position Title: Principal Manufacturing Engineer Job Location: 4245 Technology Drive, Fremont, CA (Onsite)

Department: Manufacturing Engineering Worker Category: Full-Time/Exempt

Industry: Neurovascular Medical Devices

About Q’Apel:

At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where Q’Apel comes in.

Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. We are a fast paced, high growth company with a startup philosophy which requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Who We Want:

Q’Apel is looking for a Principal Manufacturing Engineer who will contribute to the design, development, and manufacturability of Q’Apel’s innovative and fast-growing line of neurovascular/ vascular products. Our strategic advantage is our technology, time to market, and people. You will be joining a high-performance team that consistently brings winning products to the market. We are proud of the customer-focused reputation we have earned from our customers and are looking for energetic motivated individuals to join our rapidly growing team.

This role is multifaceted and varied; it will require you to have technical knowledge of assigned products so that you will be able to assure the design will meet customer and regulatory needs. You will head up the design transfer to manufacturing to assure the product can be manufactured and is cost-effective/ within budget. We will rely on your design, development, verification, and validation testing expertise to contribute to keeping the team on schedule as schedules are tight.

What You’ll Work On:

• Provide engineering expertise to the design, fabrication, development, installation, validation, and qualification of equipment /fixtures per Quality system requirements.
• Ability to set up and run product testing and protocols in accordance with project plans.
• Design, specify, assemble, and validate manufacturing equipment and processes.
• Identify and support the qualification of suppliers for materials needed for products.
• Ensure product documentation is in accordance with the Quality Management System requirements.
• Provide manufacturing engineering expertise in the daily operation and maintenance of manufacturing processes and related business continuity needs in production.
• Troubleshoot manufacturing processes and equipment.
• Work with Quality Engineering and Production personnel in the conduct of root cause analyses of material and process non-conformances (NCMRs) and implementation of corrective actions (CAPAs).
• Work with R&D and Production personnel to manufacture products for Design Verification and to transfer new products and processes into the manufacturing environment in-house or to an external contract manufacturer.
• Lead engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodies, as required.
• Support the Quality System and Quality Policy. Be compliant with Quality System procedures and requirements, including regulatory requirements, and training requirements. Initiate corrective actions regarding concerns involving product quality as needed.
• Other duties as assigned.

What You Bring:

Education:

• Masters’s Degree in Engineering or related discipline or equivalent related experience in the medical device industry.

Experience & Skills:

• 10+ years’ experience in an engineering or related experience in the medical device industry, preferably in the Neurovascular/ Vascular device industry. Strong preference will be given to those with experience with Catheters
• Knowledge of FDA regulations, guidelines, and policy statements.
• Knowledge of international regulations, standards, and guidelines such as MDD, ISO 13485, and Risk Management)
• Effective/ Excellent verbal and written communications
• Project management experience and detailed project planning are desirable
• Familiar with Design Control procedures and requirements.
• Ability to work independently or in a team setting required.
• Communicating effectively across all levels of the organization
• Works well under pressure, organized and self-motivated
• Use of critical thinking, problem solving and analysis
• Use of statistical experimental design and analysis techniques. Working knowledge of Statistical Process Control (SPC), Six Sigma principles and tools, and decision-making tools
• Use CAD software such as Auto cad, Solid Works
• Ability to travel to contract manufacturers, attend training activities, and visit suppliers, etc. will be required periodically.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $190,000 to $215,000 + equity + benefits.