OPPORTUNITIES
Software Quality Manager
Our Software Quality Manager is responsible for providing leadership and direction during new product development to ensure that the design, development and verification of product software complies with product specifications and regulatory requirements. As you are our first SQM, you will have the opportunity to build your team and your function from the ground up. You will manage both internal and external resources to develop verification test plans and oversee execution of protocols.
Primary Responsibilities
- Participating in new product development projects to ensure software used in the development and manufacture of our medical device systems are developed, deployed and maintained in accordance with the Company's and regulatory requirements. Ability to generate appropriate software development life cycle deliverables as required per IEC 62304 optimal.
- Contributing to the software development processes, software requirements analysis and software documentation, including but not limited to software requirements specification, software design description, software test plans and software test procedures.
- Managing the development of both automated software tests and manual software test protocols to ensure that software complies with performance, safety and regulatory requirements.
- Promoting a structured software verification process. Championing the automation of verification protocols when appropriate and overseeing their implementation.
- Participating in new product development team design control meetings and design reviews.
- Performing Failure Mode Effects and Analysis (FMEA).
- Reviewing and approving project software deliverables for compliance against applicable standards and internal protocols.
- Writing technical reports to support submissions to regulatory agencies.
Qualifications
- Bachelor's degree in Computer Science or Software Engineering or equivalent experience.
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8+ years working in an FDA regulated industry as a Software or Quality Engineer required. Includes a minimum of 3 years in a medical device company and 3+ years in a supervisory role.
- Strong working knowledge in one or more of the following languages: C, C#, C++, or PERL.
- Strong knowledge of external standards, including Part 820, ISO 13485 and IEC 62304.
- Experience with NUnit and/or other test development frameworks optimal. Experience with automated verification tests preferred.
- Previous experience with medical device and Class III implantables a plus.
- Experience with new product development and product realization required with start up or small company experience optimal.
The Intangibles
- Demonstrates sophisticated level of engineering-focused thinking that is based on both driving business objectives and product quality/reliability improvements.
- Ease with developing strong working relationships to ensure superior customer service and solutions.
- Extremely organized with strong analytical and problem solving skills.
- Strong, effective presentation and interpersonal skills.
- Superior project management & organizational skills, proven record of consistently following through on commitments.
- Comfortable working within a start-up environment.
- Exceptionally team focused, self-motivating and passionate for innovation and quality.
- Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
Please send your cover letter and resume via email to: , (please put "455244" in the subject line). No phone calls or recruiters please.
NeuroVista is proud to be an equal opportunity employer.