Senior Engineer

Position Summary  

We are seeking an Engineer that displays exceptional enthusiasm and a positive attitude to join our dynamic engineering team. In this role, you will be responsible for leading and managing engineering projects from conception to completion, ensuring compliance with regulatory standards and industry best practices. You will collaborate with cross-functional teams, including R&D, quality assurance, and manufacturing, to develop and optimize manufacturing processes, drive continuous improvement initiatives, and provide technical guidance to junior engineers.

Key Responsibilities

• Develop and implement robust manufacturing processes, ensuring the process designs are capable of meeting Customer TAKT, and ensuring process adherence to regulatory standards, quality guidelines, and best practices.
• Lead Kaizen workshops improving Innofiber’s manufacturing and business processes.
• Drive continuous improvement initiatives to enhance product quality, reduce costs, and increase manufacturing efficiency.
• Demonstrated experience in fostering a collaborative team environment, with a strong emphasis on cross-functional coordination, facilitating open communication, and effectively managing diverse engineering talents to drive project completion and achieve organizational goals.
• Collaborate with cross-functional teams to define project requirements, set goals, and establish project timelines including managing project scope with Innofiber’s Commercials Sales team.
• Conduct feasibility studies and risk assessments to evaluate design concepts, process capabilities, and equipment requirements.
• Set up project milestone and design reviews, ensuring compliance with Customer requirements and regulatory requirements.
• Provide technical expertise and guidance to the Engineering team, troubleshooting and resolving complex engineering issues.
• Stay up to date with industry trends, emerging technologies, and regulatory changes relevant to medical device manufacturing.
• Prepare and manage appropriate revision controls for all technical documentation, including engineering specifications, manufacturing instructions, and validation protocols.

Qualifications/Experience/Education

• Bachelor’s or Master’s degree in engineering (Mechanical, Electrical, or Biomedical Engineering preferred).
• A minimum of 5 years of experience in engineering roles within the medical device manufacturing industry is preferred.
• Proficient in CAD software (SolidWorks is preferred) and other engineering tools.
• Proven experience in leading and managing engineering projects, from concept to commercialization.
• Effective communication skills with the ability to effectively present technical information.