Address
Form of work
SalaryYou will be a key contributor working in a small team environment to help maintain our manufacturing operations & supply chain. Depending on candidate experience this position will either be on a Manager level or a Senior Manager level.
Description
About Alio
Alio, Inc. is a medical technology company bringing peace of mind to people with chronic conditions through non-invasive, wireless remote patient monitoring. Currently, Alio uses its SmartPatch™ technology to monitor individuals with end stage kidney disease (ESKD) undergoing dialysis. Alio's platform uses artificial intelligence (AI) to analyze data and create actionable insights These insights enable targeted interventions with the potential for improved health outcomes and reduced hospitalizations. Alio has built a team of seasoned leaders with diverse backgrounds spanning across industries and segments such as medical devices, wearable technology, government relations, commercialization, and reimbursement. Visit our website for more information: https://alio.ai.
The Role
Reporting to the Sr. Director of Technical Operations and Program Management, you will partner with our contract Manufacturing site to:
- Oversee and direct the planning and execution of daily manufacturing activity within Alio and at all contract manufacturing locations for medical devices.
- Monitor and report yields, throughput, finished goods, inventory count, KPI’s at all times. Monitor manufacturing expenditures and report variances to the Operations Manager on a monthly basis.
- Assist in material and operations planning to ensure the availability of raw materials, components & finished product.
- Responsible for inventory, materials movement, and order fulfillment. Support logistics, operations, customer service, and purchasing. Analyze data and generate reports to support Supply Chain & Operations. Maintain fill rate and target on time shipment of 100%.
- Ensure any changes in processes and procedures are properly implemented, meeting ISO13485, quality, and regulatory requirements.
- Partner with manufacturing engineers to execute line validations (such as I/O/PQ’s) for optimization and commercial scalability. Assist with the development of long-term plans for product life-cycle management, cost reduction, and continuous improvement.
- Proactively identify line/process improvements, cost reduction initiatives, and maintain supply chain continuity.
- Lead meetings and be the primary point of contact with external vendors for regular manufacturing plans to meet clinical and commercial demand.
- Communicate available supply, lead times, and forecasts to internal cross functional teams such as clinical, commercial, and financial teams.
- Manage and review quotes, ability to draft RFI/RFQs as needed. Drive manufacturing PO’s to completion.
- Participate in audits as the lead representative for manufacturing operations and supply chain practices.
- Work closely with Quality groups to ensure compliance with applicable quality standards and requirements of company QMS.
- Monitor operations performance and problem analysis to reduce unscheduled downtime, minor equipment stops, breakdowns, process upsets, material quality losses.
- Maintain BoM’s, travelers, work instructions, SOP’s, and related procedural documentation to accurately reflect manufacturing line activities.
- Analyze, report, and complete daily production reports.
- Partner with CMO to schedule, train, and mentor manufacturing crew so that they can produce at maximum efficiency.
- Ensure adequate staffing, direction, corrective action, and documentation is implemented.
- Foster a culture of continuous improvement and champion operational excellence goals and initiatives.
- Work cross-functionally with all departments and leaders impacted by Manufacturing activities; including Supply Chain, R&D, software development, IT, Sales and Marketing, Development, Instrument Calibration Services (ICS), and Finance.
- Prepare documentation, reports and standard operating procedures as required
- Select, develop, and evaluate personnel to ensure the effective and efficient operation of the manufacturing team.
- Support implementation of a standard or custom ERP system within manufacturing.
Skills and Qualifications:
- 5-7 years’ experience in related field preferred
- Experience manufacturing medical devices in an ISO13458 environment
- Excellent time management skills and ability to multi-task and prioritize work
- Attention to detail, problem-solving skills, and ability to analyze data
- Excellent written and verbal communication skills
- A team player with strong organizational and planning skills
- Proficiency in MS Office, including Excel, Smartsheets, Confluence, QMS systems. Experience in ERP systems is a plus.
- Ability and willingness to learn and adapt
- Ability to manage direct report(s)
- Expected to travel up to 25% or as needed
Alio is an Equal Opportunity Employer.
Attractive compensation package and benefits includes but are not limited to:
❤️ Health
Dental
Vision
401(k)
Options
11 Paid Holidays
Unlimited Paid Vacation Days
Generally, our employment offers fall between the minimum and midpoint of the range to allow for continued salary growth during your employment at Alio. The upper half of the range accommodates this growth and supports our intention to create an environment that encourages lasting relationships between Alio and our team members.
Health benefits will be effective the first of each month following the initial hire date.
Salary
$140,000 - $190,000 per year
