Project Manager (Manufacturing Engineer)

Tegra Medical Holdings LLC•Franklin, MA

9d•$96,000 - $120,000•Onsite

About The Position

Join Our Team at Tegra Medical! We’re a trusted contract manufacturer for some of the biggest names in the medical device industry. Known for taking on complex projects that others can’t, we pride ourselves on precision and innovation. Headquartered in Franklin, MA, Tegra Medical is part of the global SFS Group, based in Heerbrugg, Switzerland. Together, we’re shaping the future of healthcare. Job Summary The Project Manager – Engineering leads and coordinates cross-functional engineering and manufacturing projects from initiation through closure, including root-cause investigations, corrective-action and continuous-improvement initiatives, cost-reduction and supplier projects, equipment implementation and other manufacturing-support efforts. The role owns project execution—schedules, milestone tracking, action follow-up, status reporting and issue escalation—and coordinates the resources, meetings, supplier activities and cross-functional dependencies that keep projects on objective and on time. The Project Manager may lead structured problem-solving but does not replace the technical authority of Engineering, Quality, Operations or other subject-matter experts; technical, process-development, Quality and commercial decisions remain with the responsible functional owners.

Requirements

Strong project-planning, organization and follow-through skills, with the ability to manage multiple projects and competing priorities.
Ability to lead cross-functional teams without direct authority; experience leading cross-functional technical or operational projects required.
Strong meeting-facilitation, action-management and written and verbal communication skills, including clear reporting of status, risks and decisions to management.
Working knowledge of structured root-cause and corrective-action methods; experience with root-cause analysis, corrective action or continuous improvement required.
Working knowledge of manufacturing processes, process validation, equipment qualification, change control and quality-system requirements preferred.
Ability to challenge assumptions respectfully and maintain accountability.
Proficiency with Microsoft Project or comparable scheduling software.
Proficiency with Microsoft Excel, PowerPoint and other project-reporting tools; project-management, Lean, Six Sigma or structured problem-solving training preferred.
A bachelor's degree in engineering or a related technical discipline and a minimum of three to five years' engineering experience in a manufacturing environment is required.
Experience in a medical-device, pharmaceutical or another regulated manufacturing environment is strongly preferred.

Nice To Haves

Working knowledge of manufacturing processes, process validation, equipment qualification, change control and quality-system requirements.
Project-management, Lean, Six Sigma or structured problem-solving training.

Responsibilities

Lead assigned projects from authorization through implementation and formal closure, defining scope, objectives, deliverables, milestones and completion criteria with sponsors and stakeholders.
Develop and maintain project schedules identifying activities, dependencies, owners and due dates, and set a review cadence based on complexity, urgency and business impact.
Track actions, decisions, deliverables and open issues to completion, holding team members accountable for agreed commitments and dates.
Identify and escalate schedule delays, resource constraints and unresolved dependencies to the appropriate functional or site leadership.
Provide regular status reports on progress, milestones, open actions and risks; verify deliverables are accepted before closure and document lessons learned.
Lead structured root-cause and corrective-action projects, facilitating problem-solving with methods such as 8D, DMAIC, 5 Whys, cause-and-effect or fault-tree analysis.
Ensure the team establishes a clear problem statement, containment plan, investigation strategy and measurable success criteria.
Coordinate data collection, testing and technical analysis, ensuring actions are assigned to qualified subject-matter experts.
Drive timely containment, root-cause analysis, corrective-action implementation and effectiveness verification supported by objective evidence.
Escalate stalled investigations or unresolved disagreements and support investigation summaries, reports and presentations; technical experts remain responsible for technical conclusions.
Coordinate activities and resource needs across Engineering, Quality, Operations, Materials, Maintenance, Purchasing, Customer Service and other functions.
Run project meetings—agendas, decisions and action items—and manage dependencies so one group's work does not unnecessarily delay another's.
Coordinate supplier schedules, technical reviews, quotations, deliverables, installations and open actions.
Coordinate customer and external communication through the appropriate Program Management, Customer Service, Quality or commercial representative, and document decisions and scope or timing changes.
Support validation and qualification planning by coordinating schedules, resources, prerequisites and required deliverables.
Track equipment qualification, process validation, inspection, documentation, training and production-readiness activities, and coordinate implementation with Engineering, Quality and Operations.
Identify and escalate open items affecting production release, and support transition of completed projects to the responsible owner once documentation and training are complete.