Senior Principal Engineer - Aerospace/Medical Devices

Job Description :

Responsibilities may include the following and other duties may be assigned.

- Collaborate with stakeholders to translate requirements into platform solutions and evaluate emerging technologies.

- Design, develop, test, document software components, and resolve infrastructure/application issues.

- Lead CAPA, field investigations, and capacity planning for platform growth.

- Maintain technical documentation and drive continuous improvement with Agile/Scrum.

- Interface with cross-functional teams, ensuring compliance with standards and regulations.

- Report to the Engineering Director and collaborate with global teams, vendors, and stakeholders.

- Assess design changes, applying Model-Based Systems Engineering and ensuring safety and risk management compliance.

- Mentor junior engineers, track deliverables, and support occasional travel.

TECHNICAL SPECIALIST CAREER STREAM :

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS :

Autonomy :

- Recognized master in professional discipline.

- Works independently to implement strategic goals and establish operational plans for job area.

- Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results.

Organizational Impact :

- Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results.

- Implements strategic goals established by functional leadership.

- Changes or may establish operational plans for job area with long-range impact on results.

Innovation and Complexity :

- Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection.

- Develops solutions to unique issues. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation.

Communication and Influence :

- Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters.

- Conducts briefings with senior leaders within the job function.

- Negotiates with others to reach understanding or agreement.

Leadership and Talent Management :

- Frequently provides guidance, coaching and training to other employees.

- Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross-functional teams.

Required Knowledge and Experience :

- Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience.

- May have deep knowledge of project management.

Must Have : Minimum Requirements :

- B-Tech/BE in Computer Science/Electronics or equivalent with 17+ years of relevant experience

- ME/M-Tech in Computer Science/Electronics or equivalent with 15+ years of relevant experience.

Skills & Experience :

Industry Experience & Domain Knowledge :

- Experience in the Medical Device Industry or related field.

- Experience in regulated environments and global regulatory compliance.

- Prior experience with FDA Class I, II, and III Medical Device systems.

- Understanding of complex embedded systems and software.

- Familiarity with networking protocols.

Technical Expertise :

- Expertise in Embedded C/C++ within RTOS development environments.

- Hands-on experience in Embedded/Firmware Device Drivers.

- Proficient in hardware/software interfacing and design.

- Desired experience with Qt, SQLite, Linux Yocto, and Security.

- Strong understanding of software development and system design.

Software Development Practices :

- Proficiency in Agile software development processes.

- Experience with change control, requirements management, and source code control.

- Conduct Code Reviews, Static and Dynamic Code Analysis.

- Generate software metrics for Unit and Integration Testing.

Team Collaboration & Communication :

- Strong interpersonal, presentation, and organizational skills.

- Ability to work in flexible settings and different time zones.

- Ability to work in a team environment and directly contribute to its success.

- Participate in system design and coordinate with teams and internal product management.

- Leadership and mentoring skills; able to manage diverse relationships and work with higher management.

Core Competencies :

- Intellectual Horsepower, Technical Ability, Team Building, Identifying and Developing Talent.

- Dealing with Ambiguity/Change, Manage Diverse Relationships, Organizational Ability.

- Comfort Around Higher Management.

Full Product Life Cycle & Cross-Functional Collaboration :

- Demonstrated experience in full product life cycle development.

- Collaboration with cross-functional teams (software, mechanical, hardware, reliability, quality, and regulatory).

Communication Skills :

- Superior written and verbal communication skills required.

Nice to Have :

- Experience with designing for the Hardware/Firmware and wireless interfaces of electronic devices with user-centric design practices

- Knowledge of OOA&D and familiarity with UML is strongly desired.

- Experience working with designing systems in a regulated environment (e.g to meet ISO and Quality system regulation requirements, including IEC 60601-1, -2, -6, IEC 62304, ISO-14971, FDA 21CFR820.30, for Class I, II and III medical systems.

- Proven experience delivering software using .Net, C, Java, Python, Golang, or similar languages

- Understanding of cloud native architecture. AWS & Azure experience