Location: San Diego, CA
Company: QFocus Technologies LLC
Domain: Manufacturing Operations
The Packaging Engineer II/III will be an essential team member in orchestrating consumables materials, equipment and instrumentation packaging initiatives for new product introductions, scale-up activities, supplier transitions, cost improvement programs and supply resilience projects across multiple businesses and product lines of our Medical Devices customer. This highly visible position in the Corporate Operations Department will lead and support impactful business initiatives involving custom packaging solutions such as crating, temperature controlled cold chain shippers, thermoform trays, Tyvek lids, pouches, and primary, secondary and tertiary packaging systems. The role requires strong organizational leadership, clear communication, analytical rigor and the ability to influence internal and external partners to deliver strategic business objectives across the global network, including San Diego, Boston, NJ, Costa Rica and EMEA.
The six guiding principles that guide Packaging Engineers are:
- Deliver Extraordinary Quality
- Cultivate Healthy Working Relationships
- Be Influential
- Communicate with Clarity
- Embrace Challenges with a Growth Mindset
- Increase Organizational Value through Specialized Knowledge
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities, as reasonably required by business needs:
- Lead defined packaging VA/VE and supplier optimization workstreams for consumables and related components.
- Analyze packaging cost drivers, freight efficiency, damage performance and material utilization to identify improvement opportunities.
- Develop and maintain packaging roadmaps for assigned product families, including cost, quality, sustainability and supply resilience considerations.
- Partner with Supply Chain, Manufacturing, R&D, Quality, Regulatory and Finance functions to align packaging priorities with product roadmaps and operational constraints.
- Support supplier selection by comparing packaging proposals, cost breakdowns, technical capability and validation readiness.
- Conduct packaging-focused due diligence for moderate- to high-risk suppliers, including review of quality systems, testing capability and capacity constraints.
- Develop, maintain and standardize packaging specifications, test requirements, and documentation used across approved suppliers.
- Provide costed packaging alternatives, risk assessments and technical recommendations to support sourcing and negotiation decisions.
- Own small-to-medium packaging projects such as new pack designs, alternate packaging supplier introductions, material changes and line transfer support.
- Perform packaging design, modeling, documentation and change control activities to meet performance, regulatory and manufacturability requirements.
- Plan and execute packaging validation activities, including line trials, distribution testing and analysis of test results and failure modes.
- Coordinate implementation of new or revised packaging into production with Manufacturing, Logistics, Quality and supplier teams.
- Manage the execution of large Consumables Engineering programs, often at supplier sites, from onset through completion including requirements, estimation, planning, design, fabrication, testing and validation.
- Expertise in scheduling with MS Project including Gantt chart development, resource estimation and critical chain scenario planning.
- Monitor packaging quality metrics, including damage rates, rework, complaints and supplier performance, and drive corrective actions where needed.
- Create internal and supplier dashboards, charts and reaction plans based on analyzed data to monitor trends and program status.
- Maintain packaging libraries, specifications, digital records and SharePoint repositories to ensure traceability and compliance.
- Implement continuous improvement ideas to reduce cost, improve time to market, enhance product quality and strengthen supply chain resilience.
- Follow established qualification, risk assessment, change control processes and recommend improvements within guidelines.
- Establishes and maintains productive working relationships with suppliers and cross-functional partners.
- Plans and organizes work efficiently to manage time wisely and prioritize tasks within a dynamic and fast-paced working environment.
- Maintains an appropriate focus on outcomes and accomplishments, persisting until objectives are achieved and conveying a sense of urgency when appropriate.
- Creates an open and accessible environment that encourages flow of information.
- Readily offers opinions and takes action; willing to challenge others appropriately when required.
- Effective in flexing individual style to direct, collaborate, persuade or motivate people as the situation requires.
- Establishes and models standards that guarantee exceptional quality.
- Exhibits a high level of energy and is self-motivated to sustain ambitious work.
- Takes action without being prompted and performs steadily while maintaining emotional control in stressful situations.
- Writes clearly and concisely, and composes information based on the specified audience.
- Offers full attention when others speak, giving cues of interest and summarizing to ensure understanding.
- Considers future impact when making decisions while understanding the organization's current strengths and limitations.
- BA or BS degree, preferred in Packaging Engineering, Science, Engineering or Project Management.
- Lean Manufacturing and/or Six Sigma Certification preferred but not required.
- Project Management Professional (PMP) Certification preferred but not required.
- Packaging engineering experience in a regulated medical device, biotech, pharmaceutical or similarly controlled manufacturing environment.
- For Level 2: 2–5 years of relevant experience in packaging engineering, manufacturing, supply chain or supplier quality.
- For Level 3: 5–8+ years of progressive packaging engineering experience with demonstrated ownership of complex projects and key supplier interactions.
- Working knowledge of packaging materials, converting processes, design practices and test methods relevant to consumable products.
- Proficiency with CAD or packaging design tools and statistical analysis of test results; Minitab or equivalent preferred.
- High proficiency with MS Office, MS Project and MS SharePoint; experience with ERP/PLM or document control systems preferred.
- Ability to manage multiple work streams and communicate clearly with suppliers and internal partners.
- Working knowledge of cGMP, FDA regulatory compliance, ISO 13485, FDA 21 CFR Part 820 and related industry guidance.
- Exposure to sustainability initiatives, global shipping requirements and regulatory labeling standards is preferred.
- Level 2: Owns defined packaging work streams, supports supplier evaluation and independently drives small to medium projects within approved guidelines.
- Level 3: Serves as technical and project lead for major packaging initiatives, mentors junior engineers and drives measurable business impact across assigned commodity areas.
- Approximately 0-10 times annually, usually less than one week in duration for each occurrence.
- Must follow all applicable FDA regulations and ISO requirements.
QFocus Technologies LLC is an Equal Employment Opportunity employer.
We are a group of passionate and experienced technology professionals working together with a singular focus to delight our customers by delivering quantifiable value and becoming a natural extension of your team!
ops@QFocustech.com
+1-858-208-3015