Senior Project Engineer , R&D

Description

The company is a global medical device maker with about a century of work in insulin delivery and diabetes care, now widening its range to reach more patients, providers and communities worldwide.

This role leads cross-functional projects on the injection products portfolio. The work covers regulatory compliance, product changes, and keeping the business stable while it grows.

Responsibilities

• Run cross-functional project teams on work affecting compliance, form, fit and function, cost reduction, line extensions and other business openings.
• Serve as the main point of contact between business leaders, functional managers and project members.
• Work with functional managers to assign people and discretionary budget so timelines hold.
• Set up and run regular project meetings so everyone stays informed, aligned and closing their actions.
• Partner with technical subject matter experts to define, plan and carry out every project task clearly.
• Judge how change requests affect risk, cost and schedule.
• Own engineering change deliverables through every Change Control stage, doing some of the hands-on work yourself when needed.
• Report quality, schedule, cost and overall progress to senior management.
• Build strong planning and execution discipline across all project work so projects deliver.

Requirements

• Hold a bachelor's degree in an engineering or technology-related field.
• Have at least 5 years of work in regulated medical device and/or pharmaceutical industries.
• Have managed product lifecycles in high-volume manufacturing environments.
• Understand structured product development, regulatory requirements and quality systems well.
• Have worked with ISO standards, GMP guidelines, FDA regulations, device design controls and manufacturing scale-up.
• Communicate clearly and well with diverse audiences and stakeholders.
• Work effectively both alone and as part of a cross-functional team.
• Pay close attention to detail and take quality and compliance seriously.

Conditions

The role is hybrid.

The company is an equal opportunity and affirmative action employer and does not discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.