Packaging / Product Development - Engineer 2

• Ability to manage competing priorities in a fast-paced environment
• Attention to detail
• Good problem-solving, organizational, analytical and critical thinking skills
• Good written and verbal communication skills and interpersonal relationship skills
• Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)
• ISO 11607
• Medical Device Design Control
• Packaging Engineering
• Protocols writing
• Scientific Technical Writing

• Support the design, development, and qualification of packaging systems for sterile and non sterile medical devices under the guidace of senior engineers, ensuring compliance with applicable domestic and international standards.
• Assist with the execution of design control activities for low to moderate complexity projects, including development and maintenance of packaging specifications and documentation.
• Participate in packaging development projects from concept through verification and transfer, supporting testing, analysis, and documentation activities to meet defined requirements, timelines, and quality standards.
• Help translate product and customer requirements into packaging and process requirements with mentorship from experienced engineers.
• Contribute as a team member on cross functional project teams (R&D, Quality, Manufacturing, Regulatory, Supply Chain), supporting packaging strategy discussions and execution.
• Execute assigned technical tasks with a strong sense of ownership and accountability, escalating risks or issues appropriately.
• Prepare and maintain technical documentation such as test protocols, reports, work instructions, and change control documentation in compliance with quality system requirements.
• Support packaging verification and validation activities, including sample preparation, coordination of testing, data collection, and basic data analysis.
• Apply fundamental engineering principles to solve packaging related problems and support continuous improvement initiatives.
• Actively develop technical knowledge in medical device packaging through training, standards review, and on the job learning.

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.
• 1–3 years of experience in packaging engineering, engineering internships/co ops, or a related engineering role; medical device, pharmaceutical, or regulated industry exposure is a plus.
• Basic understanding of medical device packaging concepts, including sterile barrier systems and non sterile packaging.
• Familiarity with relevant packaging and quality standards such as ISO 11607, ISO 13485, and packaging related ASTM or ISTA standards (coursework or practical exposure acceptable).
• Foundational knowledge of engineering statistics and data analysis; exposure to Design of Experiments (DOE) or Six Sigma concepts is a plus.
• Ability to support the development and documentation of packaging requirements and specifications with guidance.
• Familiarity with CAD and packaging design tools (e.g., CAPE, TOPS, SolidWorks, or similar) preferred.
• Strong written and verbal communication skills, with the ability to document technical work clearly and communicate effectively within a team environment.
• Strong organizational skills, attention to detail, and willingness to learn in a regulated, quality driven environment.

Pavan.p@sunrisesys.com