Full Spectrum Software

Director Of Engineering- Medical Device Software

Engineering Manager in Boston, MA

Posted 2019-01-04

Who We Are:
Full Spectrum Software is a leading provider of software development and testing services. We boast an over 20-year history in successfully designing and developing over 400 Class I, II and III medical device and non-medical solutions. As one of the earliest ISO 13485 certified software providers in the domain, Full Spectrum has a proven track record of helping our customers translate their business objectives into successful commercial products.
Director of Engineering – Medical Device Software
The Director of Engineering for Medical Device Software is a key leadership position where you will use your knowledge of the medical device industry to collaborate with our clients to shape new and innovative solutions for medical devices. This role involves both tactical and strategic components. You will not only work with our development teams as they define and implement software solutions for our clients’ projects, but will also participate in continuous improvements to our engineering, quality and business processes and objectives.
Tactical / Day to Day:
Provide technical guidance to multiple cross-functional teams throughout all phases of the software development life cycle for medical device software, including planning, requirements definition, design, development, testing and documenting, under design control, in compliance with FDA/CE regulations (e.g., ISO 13485, IEC 62304).
Work with a staff of project managers, technical project leads, and team of seasoned software development and quality engineers to ensure projects meet customer needs, are designed and developed to a high quality standard, are completed on time and within budget, and deliver a high level of customer satisfaction.
Oversee the design, implementation and documentation of medical device software under design control to ensure compliance with Quality System procedures, including document control, design reviews, code reviews and unit and integration testing.
Work with our client stakeholders, hardware partners and internal Technical Project Leads to develop system and software architectures.
Participate with clients and internal and external resources in software risk, cybersecurity risk and human factors engineering analysis activities.
Work with internal project managers to coordinate resources across client projects.
Manage client relationships and cultivate ongoing customer trust.
Speak with a wide range of client representatives at various organizational levels (e.g., executive, project management, technical staff), in large and small groups.
Provide coaching to the technical teams in support of a client-forward business model where the goal is making our clients successful.
Participate in the development of new client opportunities by working with business development staff in exploring client needs, communicating our technical expertise, and proposing new technical solutions to clients and prospects.
Participate in the Management Team for ongoing improvements to our Quality System. Communicate Quality Objectives to the technical staff and work to imbue the spirit of the objectives among team members.
Drive ongoing organizational knowledge growth and technical and process improvement using modern tools and technologies.
Required Qualifications:
5+ years’ experience managing technical teams in development of medical device software.
Experience shipping and supporting commercial software products to the field.
Experience working with a variety of product operating environments, such as MS Windows, Linux, embedded environments (bare metal, RTOS), mobile, web.
Experience leading, mentoring and growing a software development team.
Experience working in both Waterfall and Agile development environments.
Demonstrated commitment to high quality.
Bachelor’s degree in computer science or related engineering discipline.
Essential Skills:
Thorough understanding of the software development life cycle and applicable regulatory and quality standards and procedures for medical device software development.
Strong interpersonal skills with demonstrated ability to motivate cross-functional teams and promote a collaborative approach to problem-solving in a fast-paced environment.
Strong communication skills, both verbal and written. Ability to communicate technical information to non-technical audiences.
Strong analytical skills.
Expert understanding of object-oriented design principles and modern software development best practices.
Ability to define system architectures across a variety of platforms.
Strong business acumen, with demonstrated ability to balance competing needs and manage stakeholder expectations.
Nice to Have:
Experience using TFS, Jira or equivalent.
Strong knowledge of embedded software development (bare metal, RTOS, *nix).
Strong knowledge of mobile software development (iOS / Android).
Competitive salary and benefits including 401k, paid vacation time and health insurance.

Required Skills
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