Job descriptions for medical device makers: define the skill, not just the task

Open the personnel file of a final bench inspector in a typical instrument workshop. The job description reads: inspect finished instruments, maintain quality, report defects, other duties as assigned. Every word is true. None of it says what the inspector actually checks on a pair of artery forceps, which defects mean reject, who may overrule her, or what she must write down.

That gap matters in device making more than in most trades. Acceptance turns on finish, fit and traceable records. A thin layer of skilled people carries all three, a point our hub on staffing scalpels, implants and hospital beds develops. A role card that names the skill becomes a working tool. One that lists tasks becomes paperwork. GullyHR's approach to role design and skill-based descriptions starts from that difference.

• Task: polish instruments. Skill: brings jaws and shanks to the reference finish with no burn, drag lines or rounded edges, checked under the bench lamp.
• Task: assemble suction units. Skill: builds to the current drawing revision, tightens fittings to the drawing torque, and records serial and lot numbers for every sub-assembly.
• Task: operate CNC lathe. Skill: sets up a Swiss-type machine for an implant screw, proves first-off size with a micrometer and thread gauge, and holds size through the batch.
• Task: calibrate analysers. Skill: calibrates against reference samples, recognises drift outside limits, and quarantines a unit that fails.
• Task: service equipment. Skill: finds faults on site, explains them to ward or lab staff in plain words, and closes a complete service report.

ROLE TITLE: the name used on the floor, for example box-lock fitter.
SECTION AND REPORTS TO: bench or line, and the supervisor by role.
PURPOSE: a line naming what the role safeguards for the patient and buyer.
PRODUCTS AND PARTS: the instrument families, models or part numbers covered.
MACHINES, TOOLS AND GAUGES: what the person uses and must look after.
STANDARD OF WORK: finish, fit, tolerance or test result that counts as good.
RECORDS OWNED: batch record lines, lot numbers, test sheets, service reports.
AUTHORITY: may halt, reject, release or escalate, listed item by item.
GOWNING, ESD AND SAFETY: rules peculiar to this bench.
SKILL LEVELS: learner, independent, senior, master, each with its solo limits.
SIGN-OFF: who signs each level and how it is tested.
COVER: who stands in when this person is absent.
LAST REVIEW: supervisor initials, dated.

1. 1

   Start with the roles that carry quality

   Final inspectors, box-lock fitters, polishers, Swiss-type setters, calibrators and field engineers. Do these before general helpers or packers.

2. 2

   Write with the senior hand, not about them

   Sit beside the strongest hand in the role and ask what a beginner gets wrong, what they check that nobody taught them, and when they stop the work.

3. 3

   Make the standard visible

   Wherever possible, attach a reference sample, a photo or a drawing to the standard of work line. Words alone rarely capture a finish.

4. 4

   Name the authority plainly

   Inspectors and testers need written authority to reject or hold. Without it they feel pressure from dispatch and give way.

5. 5

   Set the skill levels and sign-off

   Define what a learner may do under supervision and what an independent hand may do alone. Tie every level to a pay grade.

6. 6

   Show the card to the person

   Go through it line by line with the employee and the supervisor together, agree it and keep a copy at the bench.

A card written around skill earns its keep several times. It sets the bench trial for hiring, because the standard of work line tells you what to test. It becomes the training plan, because the skill levels are the steps. It anchors pay, because each level can carry a grade. And it answers the buyer's auditor, who asks how operators are trained and whose initials clear them.

The member pages show how this plays out. Equipment builders can see roles for assembly, test and field service in role design for medical equipment makers. Analyser and reader makers face fine soldering and calibration roles, covered in role cards for diagnostic equipment units. Implant shops, with programmers, setters, polishers and CMM inspectors, are covered in implant maker role design.

• Review every card with the supervisor twice a year, and date the review.
• Update the card whenever a new product, drawing revision or machine changes the skill.
• Check the cover line each quarter so no critical role has an empty stand-in.
• Use the skill levels in every appraisal, so the card is read, not filed.

GullyHR writes skill-based role cards with device makers' own senior hands, then links them to hiring trials, training levels and grade steps. If your job descriptions read like task lists, post us a handful; rewriting begins with the inspector, fitter and tester cards.