Project Manager I - Medical Device Manufacturing

Harleysville, PA

Full Time

Mid Level

Project Manager I
On-site | Full-Time

Join Our Team
We are seeking a motivated and organized Project Manager I to join our growing Project Management team. In this role, you will help lead cross-functional projects from initiation through completion, partnering with teams across Engineering, Supply Chain, Customer Service, Product Management, Sales, and Leadership.

The ideal candidate will have Project Manager experience leading cross-functional projects within a medical device manufacturing environment. This role manages product transfers, manufacturing process improvements, equipment implementation, validation activities, regulatory compliance initiatives, and new product introductions. The ideal candidate has experience in FDA-regulated manufacturing, quality systems, and medical device production operations.

Key Responsibilities

Develop and manage project plans, schedules, milestones, and deliverables.
Coordinate cross-functional teams and external partners to ensure successful project execution.
Monitor project progress, identify risks, and implement mitigation strategies.
Manage project scope, timelines, and stakeholder expectations.
Facilitate project meetings and provide regular status updates to stakeholders and leadership.
Track project performance and ensure alignment with business objectives.
Ensure compliance with PMO processes, governance standards, and quality requirements.
Resolve project issues and escalate concerns as appropriate.
Conduct project closeout activities, including lessons learned and continuous improvement initiatives.
Build strong relationships with internal and external stakeholders.

Required Qualifications

Bachelor's degree in Business, Engineering, or a related field.
1–3 years of project coordination, project management, or related experience, or equivalent experience leading projects, process improvements, or cross-functional initiatives.
Prefer Project management experience in medical device manufacturing, life sciences, pharmaceutical manufacturing, biotechnology, or other FDA-regulated industries.
Strong organizational, analytical, and problem-solving skills.
Excellent written, verbal, and interpersonal communication skills.
Ability to manage multiple priorities in a fast-paced environment.
Proficiency with Microsoft Office applications.

Preferred Qualifications

CAPM, PMP, or other Project Management certification.
Experience with Smartsheet, Power BI, or other project management software.
Manufacturing, engineering, or supply chain industry experience.
Experience with Netlink and/or AS/400 Mapics.

What You'll Bring

Strong planning and organizational skills.
A collaborative and solutions-focused mindset.
The ability to influence and work effectively across departments.
Attention to detail and a commitment to delivering results.
Adaptability and a continuous improvement mindset.

Work Location & Schedule
This role is expected to work onsite during the first 6–12 months to support onboarding, training, relationship building, and cross-functional collaboration. Following that period, a hybrid work schedule may be available based on performance, business needs, and manager approval.

Benefits
We invest in our employees' well-being and professional growth by offering a competitive benefits package, including:

Medical, Dental, and Vision Insurance
Flexible Spending Accounts (FSA)
401(k) with Company Match
Company-Paid Life Insurance
Paid Time Off and Paid Holidays
Professional Development and Training Opportunities

Travel
Occasional domestic and international travel may be required.

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This position is not a remote role and requires working onsite in Harleysville, PA. Are you able and willing to meet this requirement?*

Are you legally authorized to work in the United States for any employer?*

Will you now or in the future require employment visa sponsorship?*

How many years of project management, project coordination, or project leadership experience do you have?*

Have you led or coordinated a project involving multiple departments, stakeholders, or team members?*

Have you been responsible for driving project deliverables from team members who did not report directly to you?*

Which best describes your leadership experience?
• I have not led projects or teams.
• I have coordinated project activities and worked with cross-functional teams.
• I have led project teams without direct supervisory authority.
• I have formally supervised employees and led project teams.*

What level of responsibility have you had for project management?
• Assisted with project administration and scheduling
• Coordinated project activities and reporting
• Owned small to mid-sized projects from start to finish
• Owned multiple projects simultaneously from initiation through completion*

How many years of project management experience do you have within medical device, pharmaceutical, biotech, or other regulated manufacturing environments?*

Which project management tools have you used?*

What are your annual base salary expectations?*

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Project Manager I - Medical Device Manufacturing

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