Senior Manufacturing Engineer

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 that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Who We Want:

The Senior Manufacturing Engineer role based in Fremont, CA, will play a pivotal role in supporting various Warehouse functions. These responsibilities include

Responsible for contributing to the design, development, and manufacturability of neurovascular products in accordance with the company’s Quality System and customer requirements. The role is multifaceted and varied; it requires technical knowledge for assigned projects or products to ensure the design and development process is followed and will include but is not limited to design, development, verification and validation testing, transfer to manufacturing, and continuous enhancements/ improvements to the products. Supports the design transfer to manufacturing activities to ensure the product can be manufactured and is cost-effective/ within budget in a fast-paced environment.

Position Responsibilities and Authorities:

• Lead the development of design specifications to assure manufacturability.
• Lead the set up and run product testing and protocols in accordance with project plans.
• Lead process and design improvement activities to gain efficiency and quality.
• 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 the assigned manufacturing processes and related business continuity needs in production and to contract manufacturer as needed. Troubleshoot and correct 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 product for Design Verification and to transfer new products and processes into manufacturing environment in-house or to an external contract manufacturer.
• Provide engineering expertise to the design, fabrication, development, installation, validation, and qualification of equipment /fixtures per Quality system requirements.
• Successfully lead the process of transferring NPI products into the manufacturing environment from development.
• Support engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodies.
• Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements, training requirements for position. Communicate concerns involving product quality as needed.
• Other duties as assigned.

Qualification Requirements:

Education:

BS Degree in Engineering or related discipline or equivalent related experience in the medical device industry.

Experience & Skills:

• 5-7 years experience in engineering or related experience in the medical device industry, preferably in the Neurovascular/ Vascular device industry.
• Strong knowledge of FDA regulations, guidelines, and policy statements.
• Effective/ Excellent verbal and written communications
• 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
• Design, specify, assemble, and validate manufacturing equipment and processes.
• Use of statistical experimental design and analysis techniques.
• Use CAD software such as Auto cad, Solid Works
• Ability to travel to attend training activities, 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 target salary range for this position is $120k- $150k USD. The pay range for this position is a general guideline only. The salary offered will depend on internal pay equity and the candidate's relevant skills, experience, qualifications, and job market data.