As a senior leader in the R&D department, you will play a pivotal role in driving innovation and growth within our organization. This exciting opportunity is perfect for an experienced professional looking to take on new challenges and make a meaningful impact.
">
Key Responsibilities:
* Lead a team of engineers and scientists, providing guidance, mentorship, and development opportunities to ensure they reach their full potential.
* Develop and implement strategies to enhance clinical and technical knowledge and expertise within the team.
* Collaborate with cross-functional teams to support the development of departmental and program objectives, aligning them with our company's overall strategic plan.
* Ensure the health and safety of employees in test laboratories, adhering to all regulatory requirements.
* Contribute to the development and maintenance of departmental budgets and resourcing plans, ensuring effective resource allocation.
* Promote a culture of excellence and compliance, reflecting our company values in all interactions with colleagues and stakeholders.
* Implement robust engineering practices and processes in product design and development, guaranteeing reliability and quality.
* Align test plans and testing with regulatory requirements, preparing regulatory submission-ready documentation for relevant authorities.
* Support clinical activities, including limited clinical case support, and perform root cause investigations of identified product failure modes.
* Contribute to the ongoing development of our intellectual property portfolio, staying abreast of technological advancements in therapeutic domains.
* Stay informed about changing regulatory standards and their impact on planned technical work within R&D and Product Development Activities.
* May lead new product development projects, meeting patient, customer, and business needs, and may serve as project lead on one or more projects, developing plans and goals that meet overall company objectives.
* Develop project plans, timelines, budget, and resource requirements, communicating these to stakeholders, and demonstrate collaborative leadership, collaborating across multiple functions beyond R&D.
* Manage external vendors/partners as necessary to support product development activities.
Requirements:
* Minimum of Bachelor's degree in Mechanical or Biomedical Engineering or related field.
* Minimum of seven years in similar role in medical device product development, with minimum of three years in project management/leadership role of technical projects across R&D and Manufacturing as senior or principal R&D engineer.
* Good leadership and project management skills, with ability and willingness to effectively build and manage small team, demonstrated experience in people mentoring and development.
* Deep and current understanding of FDA and ISO 13485 requirements, with ability to interpret and implement them into new product development.
* Experience in design, verification, and process validation processes, broad knowledge of materials and manufacturing processes applicable to medical device industry desirable.
* Experience working with sub-contract manufacturers/suppliers/test facilities, including integration of their activities into product development activities.
* Previous experience of planning and preparation of regulatory submission to agencies, competent authorities, and/or Notified bodies.
* Excellent communication, organizational, and time management skills.
* Good problem-solving mindset, strong verbal and written communication skills.
* At ease in start-up environment and effectiveness to deliver in low-structured environments.
* Demonstrated ability to communicate within team/company structure and achieve project and company objectives.