Project Manager, Operations (Agile)

Appone; Norfolk (VA); On-site; USD 78,000 - 115,000; Full time

Benefits offered by this job

401K

Health Benefits

Wellness Program

Life Insurance

Corporate Sponsored Events

Skill growth opportunities

Short Term Disability

Ability to Advance

Energetic & creative problem solvers

Job summary

Instant Systems is seeking a Project Manager, Operations (Agile) to drive small, fast-paced operational projects in a med‑tech environment from sprint to go‑live. You will coordinate cross‑functional teams and manage change control, validation, and documentation per ISO 13485 and FDA requirements.

The role emphasizes agile sprints, daily stand‑ups, and visual boards, with a focus on benefits delivery, budget tracking, and on‑time completion.

Qualifications

• Bachelor's degree in Engineering (Industrial, Mechanical, Chemical, Biomedical) or related field.
• 4-7 years in manufacturing operations or engineering, with 2+ years leading projects end-to-end.
• Experience using Agile or Lean methods to deliver projects, ideally outside software.
• Experience in medical devices, pharma, biotech or FDA/ISO‑regulated industry.
• Knowledge of change control, equipment validation and Good Documentation Practices.

Responsibilities

• Lead cross-functional teams from Production, Engineering, Quality, Maintenance, Supply Chain, EHS and IT.
• Serve as product owner with Operations Leader, prioritizing work and involving floor staff in reviews.
• Coach teams in agile/lean practices and visual management.

Skills

Agile methods

Lean methods

Facilitation skills

Visual project tools

Education

Bachelor's degree in Engineering or related field

Tools

Jira

Azure Boards

Trello

Smartsheet

Monday.com

Microsoft Planner

Excel

PowerPoint

Job description

About the Organization By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes. We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators. If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.

Description

The Project Manager, Operations (Agile) delivers a steady flow of short, high-impact operations projects for SUS Company 1, finishing them in weeks rather than months. Typical projects include line layout and changeover improvements, fixtures and small equipment, capacity quick-wins, scrap and yield fixes, 5S and visual management, pilot runs, new customer assemblies and reporting or system improvements. The role uses agile methods (short sprints, visual boards, daily stand-ups and quick feedback loops) to deliver working results early and adjust fast. It also builds change control, validation and documentation into each sprint, so that speed never comes at the expense of compliance under ISO 13485 and FDA requirements.

Responsibilities

• Lead small cross-functional teams from Production, Engineering, Quality, Maintenance, Supply Chain, EHS and IT, often without direct authority.
• Work with the Operations Leader as the product owner who sets priorities, and brings floor operators and supervisors into sprint reviews for fast feedback.
• Coach teams and supervisors in agile and lean practices such as stand-ups, visual management, retrospectives and problem solving.
• Manage vendors and contractors for small equipment, fixtures and installations, including quick quotes, purchase requests, installation and acceptance testing.
• For larger projects (e.g., new cleanroom or production line, major equipment), use a hybrid approach: formal stage gates, business case and capital request (CapEx) at the top level, with agile sprints for design, build, test and validation work inside each phase.
• Maintain an overall milestone plan and budget for these projects, and track cost and forecast-at-completion against the approved budget.
• Hand over each result to operations with updated SOPs or work instructions, trained people and support in place.
• Confirm benefits (e.g., capacity, savings, yield, cycle time) 30-90 days after go-live against the charter.
• Capture lessons learned in every retrospective and improve templates, tools and the project process for Operations.
• Report monthly on portfolio flow: projects completed, cycle times, benefits delivered and blockers.
• Run a single intake process for operations project requests; screen each one for value, effort, urgency and compliance impact.
• Scope each project on a one-page charter or A3 within 2-3 business days: problem, goal, measurable success criteria, scope limits, team, target finish date and change-control path.
• Break larger ideas into small, independently valuable deliverables (for example: pilot on one line, then roll out to others) so results arrive early.
• Keep a prioritized operations project backlog with the Operations Leader, re-ranked every 2 weeks based on business value, risk and capacity.
• Use risk-based approval tiers so small, low-risk projects get quick sign-off, and reserve full stage-gate reviews for high-risk or high-cost work.
• Plan work in 1-2 week sprints with clear sprint goals; hold sprint planning, 15-minute daily stand-ups at a visual board on the floor, sprint reviews and retrospectives.
• Manage the project portfolio on a Kanban board (e.g., Backlog, Ready, In Progress, Validation/Documentation, Done) with work‑in‑progress limits so teams finish before they start new work.
• Deliver a minimum viable result early (e.g., a trial fixture, temporary layout or pilot run), measure it, and improve it in the next sprint.
• Remove blockers within 24-48 hours: secure decisions, parts, people and production time, and elevate quickly when needed.
• Run rapid-improvement (kaizen) events of 3-5 days with production teams for focused problems.
• Coordinate project work with Production Planning so trials, installations and cut‑overs fit into planned downtime and protect customer deliveries.
• Share progress openly with visual boards, burndown or cumulative flow charts and short weekly updates instead of long status reports.
• Treat compliance as part of "done": a deliverable is only complete when its change control, validation, documentation and training are complete.
• Screen each project at intake for impact on product, process, equipment, facility, software, customers or registrations, and choose the right change‑control path early.
• Plan validation (IQ/OQ/PQ, process and test method validation, computer system validation) with Quality and Validation from sprint one, and run documentation in parallel with the build, not after it.
• Use pre-approved templates and standard protocols for repeat project types (e.g., fixtures, like‑for‑like equipment, layout changes) to shorten approval and validation time.
• Keep project records audit‑ready in line with ISO 13485:2016, FDA 21 CFR Part 820 (Quality Management System Regulation) and Good Documentation Practices.
• Coordinate customer change notifications and regulatory assessments with Quality and Regulatory whenever a project could affect customer products.
  • Other Responsibilities as assigned

To be considered you’ll need:

• Bachelor's degree in Engineering (Industrial, Mechanical, Chemical, Biomedical), Operations Management, Business or a related field.
• 4-7 years of experience in manufacturing operations or engineering, including 2+ years leading projects end to end.
• Hands‑on experience using agile or Lean methods (Scrum, Kanban, sprints, kaizen events) to deliver projects, ideally outside pure software.
• Experience in medical devices, pharmaceutical, biotech or another FDA/ISO‑regulated industry.
• Working knowledge of change control, equipment validation (IQ/OQ/PQ) and Good Documentation Practices under ISO 13485 and FDA 21 CFR Part 820.
• Track record of running several short projects at once and delivering them on time.
• Proficiency with a visual project tool (e.g., Jira, Azure Boards, Trello, Smartsheet, Monday.com, Microsoft Planner) and advanced Excel and PowerPoint.
• Strong facilitation skills for stand‑ups, workshops, reviews and retrospectives.
• Clear written and verbal communication with operators, engineers and senior leadership.
• solid company-centric ideology.
• creative problem‑solving skills.
• the ability to balance multiple priorities.
• core values of honesty and respect.
• a thirst for learning.
• the desire to be challenged.

You will thrive if you:

• enjoy an autonomous work environment.
• have a LEAN mindset.
• are the first person to help.
• seek out opportunities to bring added value.

Company Benefits & Perks

• 401K
• Health Benefits: Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance
• Working with energetic & creative problem solvers
• A mission worthy of your energy and expertise

Full-Time/Part-Time Full-Time

Instant Systems’ provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Salary Range $78,000-$115,000

This position is currently accepting applications.