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Head of Software Engineering

2 months ago

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

The Director of Software Development will oversee the entire software lifecycle for medical device software developed in-house. This role involves collaborating with stakeholders to gather and prioritize software specifications. The director will lead a team of developers in crafting and executing software solutions.

Key Responsibilities:

  • Establish and refine the software development strategy to enhance workflow and information access for current and future product initiatives.
  • Manage software development projects, including planning, defining product requirements, prioritizing tasks, and mitigating risks.
  • Ensure projects adhere to established timelines and criteria, delivering measurable business outcomes.
  • Guide, inspire, and manage a diverse team of software engineers, both senior and junior, to achieve corporate goals and collaborate on product strategies for successful launches.
  • Participate in the recruitment and selection of new team members, oversee team development, conduct performance evaluations, and address employee concerns and conflicts.
  • Contribute to discussions on operating and capital budgets, ensuring expenditures align with approved financial objectives.
  • Comply with the company's Code of Ethical Conduct, ensuring that personal and team actions adhere to relevant policies, regulations, and laws.
  • Engage in R&D planning to support the development and introduction of next-generation technologies and services.
  • Collaborate on outsourcing decisions to enhance efficiencies and reduce product costs while safeguarding the company's intellectual property.
  • Promote a company culture focused on teamwork, empowerment, accountability, creativity, achievement, and agility.
  • Achieve project objectives within budget and timeline constraints.
  • Support company goals, policies, and procedures, including adherence to Quality System Regulations, ISO/MDD standards, and other regulatory requirements.
  • 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 applicable 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 Qualifications:

  • Creative problem-solving abilities to develop innovative solutions that support our objectives.
  • Capability to manage 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, effective decision-making, and results-driven execution.
  • Self-directed and able to thrive in a dynamic environment.
  • Ability to translate complex business challenges into clear solutions and functional requirements.
  • Experience working collaboratively across various functions, including Engineering, Design, Customer Success, Marketing, and Business Development.

Physical Factors:

  • The physical demands outlined here represent those necessary for an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities.

Working Conditions:

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

Unplanned Activities:

  • Additional duties as assigned.