New Product Quality Engineer

The New Product Quality Engineer is responsible for supporting electrical medical devices through their full life-cycle. This specific Quality Engineering position will primarily focus on electrical medical devices, including implantable pulse generators and programmers.

Key Responsibilities:

• Design assurance activities as part of new product development and process/product changes.

• Leading investigations for technically complex and challenging manufacturing nonconformities and post-market failures to identify root cause/corrective actions in a timely and compliant manner.

• Investigating anomalies identified during the development process.

• Providing value-added feedback in technical design reviews.

• Leading risk management activities throughout the product life-cycle.

• Ensuring that we are applying the right engineering approaches and methods that meet procedural and regulatory requirements for all phases of product development projects including design inputs, design transfer (process validation), design verification and validation, etc.

The Team:

This person will be working in a cross-functional environment, with a multi-disciplinary team of engineers within the Quality Engineering Department. This role interacts on a daily basis with Manufacturing Engineering, R&D Engineering, and Project Management.

You will have a demonstrable impact on the patient experience by ensuring that the devices we design, develop, and manufacture are safe and effective!

Requirements:

• BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or equivalent.

• 3 - 7 years of experience, preferably in a medical or biotechnology. industry involved in supporting electrical engineering activities such as those previously detailed above for electronic medical devices.

• Required knowledge includes electrical design, firmware/software design, and statistics.

• Knowledge in medical device regulations, including the QMS processes required to develop and manufacture medical devices is preferable.

Compensation, Benefits, and Schedule:

• The target salary for this position ranges from $85,000 - $115,000 annually plus discretionary bonus. Salary will be offered based on depth and relevance of experience.

• This role will be onsite Monday - Thursday and remote on Friday

• Great company culture: Employee Recognition Program, Service Awards, Bonus Referral Program.

• Work/life balance: Personal and Vacation Time, Flexible Work Schedules.

• Health benefits: Medical with HSA and FSA options, Dental, Vision, Life, On-site gym for employees.

• Prepare for the future: 401K Plan with company matching contributions, Employee Stock Purchase Plan, Training & Education Assistance, Adoption & Fertility Reimbursement.