Performance Health is seeking a Mgr, Packaging & External Manufacturing to join our team. In this role, you will be responsible for leading, developing, and supporting team members to maximize performance, engagement, and job satisfaction while serving as a critical link between employees and senior leadership. This role balances people leadership with operational execution, ensuring projects and business objectives are delivered efficiently, on time, and within budget.
As a working manager, the individual actively contributes to team deliverables while fostering a positive, collaborative culture built on open communication, accountability, continuous improvement, and recognition of achievements. The Manager provides coaching, mentoring, and career development through regular one-on-one meetings, goal setting, performance feedback, and alignment of individual objectives with organizational priorities.
Key responsibilities include assigning resources effectively, matching team members' strengths to business needs, removing obstacles that impact performance, and guiding cross-functional collaboration. The Manager maintains an objective and fair approach to performance management, builds trust through active listening and empathy, and promotes employee growth while avoiding micromanagement. Additionally, the role oversees priorities, budgets, timelines, and resource planning to ensure successful execution of evolving business goals and strategic initiatives.
Essential Job Duties & Responsibilities- Manage, teach and guide 4+ team members / co-ops / interns, domestically and internationally as direct reports with responsibility for reviews, goals, and timecards
- Manage and lead team through successful execution of simultaneous multiple project and project type environment while also encountering and engaging in daily business needs that arise and require resolution
- Ability to manage and coordinate among Packaging, Product, and Graphics engineering roles
- Lead complex component or system-level design BOMs and ability to build costed BOMs
- Perform, initiate, and guide team members through DHF's for component or product revision changes while maintaining proper tracking and documentation. Including specifications, BOP, SOP, tech files, DOC, 510K and related documentation requirements
- Manage and lead team through successful execution of product design and formula development
- Lead and train principles of design control and risk management to team
- Ensure documentation is clearly written and complies with company / customer requirements
- Lead and guide team members to customized product solutions for standard products in conjunction with requirements from end users.
- Excellent understanding of manufacturing processes
- Ability to drive strategic process improvements across an organization
- Assists in patent searches and review competitive patents to prevent infringement and evaluate IP potential. Work with lawyers to write and evaluate new IP opportunities
- Lead and guide team members through all phases of projects where GP&EMO responsibilities reside.
- Collaborate and explore innovation opportunities including monitoring emerging materials, sustainability, processes and technologies, and exploring new product concepts/prototypes
- Identify areas of efficiency, improved delivery, and / or cost savings. Including but not limited to packaging consolidation, savings, efficiencies to improve business positioning, graphic improvements that will create efficiency and lower cost
- Negotiate pricing situations with packaging, service, and rework suppliers
- Ability to source, identify, and approve packaging and rework suppliers as vendors
- Lead and guide team through various regulations such as, but not limited to FDA, EU-MDR, GPSR, MoCRA, PPWR, and EU-DR
- Strong understanding of regulatory guidance and core marking requirements
- Lead and guide team through NCMR, CAPA, and SCAR procedures
- Represent GP&EMO in an ISO or FDA audit when required
- Perform root cause analysis to identify effective solutions and propose design improvements using methods 5-Why, Fishbone, 8D, and others
- Lead in CAPA investigations and ability to complete timely with effective solutions
- Ability to assess and negotiate situations with cross-functional teams to bring smooth and successful results to products placed on the market
- Actively participate in actions and adjustments within projects that result in timeline achievement / success
- Actively engage in process improvement, innovation and continuous improvement in projects and processes.
- Ability to manage and prioritize tasks among fast-moving projects
- Manage cross-functional teams (e.g., supplier, Sourcing, Product Management, RA/QA, etc.) where required
- Create project charters where required for larger scale / higher visibility company issues
- Leadership and project management of design projects from conception to delivery
- Ability to create calculations including inventory estimation / predictions, Break-even analysis, and ROI
- Strong analytical and troubleshooting capabilities
- Strong understanding of GTINs, level assignments, symbology types, and GS1 allocation rules
- High-level communication skills for engaging with executives, cross-functional teams, regulatory bodies, customers, and stakeholders
- Provide technical support/leadership for the following additional business functions:
- Sourcing: Participate in second sourcing or re-sourcing products
- Product / Project: Provide timing, attribute, and budget support for future projects to aid in defining upcoming company strategic plans
- Regulatory: Provide technical input to support product registrations and complaints
- Supply Chain: Provide support in supply issues including but not limited to labeling, packaging, and rework
- Distribution: Provide technical support for resolving product inquiries and packaging issues
- Customer Service: Provide technical support for resolving product inquiries and complaints
- Performs other duties as assigned
Job Qualifications- Bachelor's degree in Engineering discipline
- 5-10 years of New Product Development experience
- 5+ years of Sourcing, Product engineering / development / innovation, Manufacturing, and/or purchasing experience
- 3+ years of management / leadership experience
- Experience working within or closely with Sourcing, Product Management, Manufacturing, Supply Chain, and RA/QA
- Ability to respond properly to common complaints from customers, regulatory, or members of the business community
- Proven ability to make quick and concise decisions
- Knowledge of Word, Excel, TOPs
- Proven ability to effectively manage multiple projects and initiatives simultaneously
- Ability to effectively present information to employees at all levels, managers, vendors, customers, manufacturing, and distribution
- Knowledge of ISO, FDA, EUDAMED regulations as they apply to medical devices and non-medical devices (in the US and international markets)
- Knowledge in basic packaging principles and GTIN application and allocation
- Demonstrate proficiency in Design Control (per FDA, ISO 13485 standards and MDR)
- Demonstrate a proficiency in product Risk Management (analysis, evaluation and control)
Benefits- Our benefits include healthcare; insurance benefits; retirement programs; paid time off plans; family and parenting leaves; wellness programs; discount purchase programs.
- This is a full-time position with a base salary range of $90,000 - $100,000 and the opportunity to earn bonus, plus benefits.
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
