Manufacturing Engineer II

Job Description

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:

We are seeking a highly skilled and motivated Manufacturing Engineer II to join our Manufacturing Engineering team. The Manufacturing Engineer II role is based out of Fremont, CA. This role will play a pivotal role in supporting and contributing to the design, development, and manufacturability of neurovascular/vascular products by 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 effective/within budget. The ideal candidate will have a minimum of five years of manufacturing engineering experience and a strong background in Manufacturing Engineering practices and regulations, excellent communication skills, and the ability to thrive in a fast-paced environment.

What you’ll Work On:

Support the development of design specifications to assure manufacturability.

Support the setup and run of product testing and protocols in accordance with project plans.

Identify and support the qualification of suppliers for materials needed for products.

Provide status reports.

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 manufacturers as needed. Troubleshoot manufacturing processes and equipment.

May provide customer training to ensure products designed by Q'Apel are understood.

Provide engineering expertise to the design, fabrication, development, installation, validation, and qualification of equipment /fixtures per Quality system requirements.

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.

May be required to lead or contribute to the process of transferring the design into the manufacturing environment from development.

Perform job functions in a safe and effective manner.

Support 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 aware of Quality System procedures and requirements, including regulatory requirements, and training requirements for the 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 years minimum experience in engineering or related experience in the medical device industry, preferably in the Neurovascular/ Vascular device industry.

Knowledge of FDA regulations, guidelines, and policy statements.

Knowledge of international regulations, standards, and guidelines (current MOD, ISO 13485, CMDR, J-GMP, Risk Management, Usability)

Effective/ Excellent verbal and written communications

Project management experience and detailed project planning is 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

Design, specify, assemble, and validate manufacturing equipment and processes.

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

The ability to travel to contract manufacturers, 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 $100k- $130k 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.