Head of Software Engineering

2 weeks ago

Baltimore, Maryland, United States Galen Robotics Inc. Full time

Position Overview:

The Director of Software Development will play a pivotal role in overseeing the software lifecycle for medical device software developed in-house. This leadership position requires collaboration with various stakeholders to accurately document and prioritize software needs. The director will guide a talented team of developers in crafting and executing innovative software solutions.

Key Responsibilities:

  • Establish and refine the software development strategy to optimize workflows and enhance information access for current and future product initiatives.
  • Manage software development projects, including planning, scoping, and defining product requirements, while also prioritizing projects and managing associated risks.
  • Ensure that projects adhere to established timelines and criteria, delivering measurable business outcomes.
  • Lead and inspire a diverse team of software engineers, both senior and junior, directing their efforts to align with corporate goals and collaborate on product strategies for successful development and launch.
  • Engage in the recruitment and selection process for new team members, facilitate team development, conduct performance evaluations, and address employee concerns and conflicts.
  • Contribute to discussions regarding operating and capital budgets, ensuring expenditures remain within approved limits.
  • Uphold the company's Code of Ethical Conduct, ensuring compliance with applicable policies, regulations, and laws.
  • Participate in R&D initiatives that support the development and introduction of next-generation technologies and services.
  • Collaborate on outsourcing decisions to create efficiencies and reduce product costs while safeguarding the company's intellectual property.
  • Promote a culture of teamwork, empowerment, accountability, creativity, achievement, and speed within the organization.
  • Achieve project objectives within budget and timeline constraints.
  • Support the company's goals, policies, and procedures, including adherence to Quality System Regulations and ISO/MDD standards.
  • Maintain a professional image with key stakeholders, including physicians, consultants, suppliers, and colleagues.
  • Perform additional duties as required.

Essential Functions:

  • Ensure compliance with FDA requirements for GMP/QSR and ISO13485.
  • Foster a continuous improvement environment that aligns with the company's Quality Policy and relevant regulations.
  • Keep management informed of any changes in work schedules or workloads.
  • Regularly propose and implement strategies to enhance the customer experience.

Education Requirements:

A minimum of a Bachelor’s degree in Computer Science or a related field.

Experience Requirements:

At least 8-10 years of relevant experience in the medical device sector, including a minimum of 2 years in a managerial role.

Skills and Competencies:

  • Creative problem-solving abilities to advance and support innovative solutions.
  • Proficient in managing multiple, diverse projects of varying complexities.
  • Strong interpersonal and analytical skills.
  • Professional demeanor, self-motivated, team-oriented, and capable of working independently.
  • Experience with agile development methodologies.
  • Exceptional written, verbal, and presentation skills.
  • Demonstrated leadership skills, including strategic planning and effective decision-making.
  • Ability to thrive in a fast-paced environment and work autonomously.
  • Capable of translating complex business challenges into clear solutions and functional requirements.
  • Adept at collaborating across various functions, including Engineering, Design, Customer Success, Marketing, and Business Development.

Physical Requirements:

  • The physical demands of this role are representative of those required to successfully perform essential job functions. Reasonable accommodations may be made for individuals with disabilities.

Working Environment:

  • The work environment characteristics described here are typical for an employee performing essential job functions. Reasonable accommodations may be made for individuals with disabilities.

Additional Responsibilities:

  • Other duties as assigned.

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